FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

July 23, 2003
03-30

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Swatt's Salt Rising Bread, 16 oz. loaves for retail sale, and 22 oz. loaves for restaurant use. Recall # F-392-3.
CODE
All uncoded product purchased prior to 4/10/03 and all coded product with a "sell by" date of "04-16" or earlier is affected.
RECALLING FIRM/MANUFACTURER
Swatt Baking Company, Olean, NY, by on site visit beginning April 10, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE
250/22 oz. & 200/16 oz. loaves per week.
DISTRIBUTION
NY, and PA.

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PRODUCT
Ben & Jerry's Karamel Sutra Ice Cream with a Karamel Core, pint size. Recall # F-419-3.
CODE
Date Code: 02/14/04 located on the bottom of the package.
RECALLING FIRM/MANUFACTURER
Ben & Jerry's Homemade, Inc., South Burlington, VT, by telephone, fax and Press Release on March 28, 2003. Firm initiated recall is ongoing.
REASON
Ice Cream may be contaminated with peanuts.
VOLUME OF PRODUCT IN COMMERCE
84,544 pints.
DISTRIBUTION
Nationwide

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PRODUCT
Asian Boy (E.B.Q.) brand Sweet Winter Melon, Confiture de Courge, Net Wt. - Poids Net: 8 oz. (227 g). Product of Vietnam. Recall # F-420-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
B.C.N. Trading, Inc., Brooklyn, NY, by press release on February 26, 2003. New York State initiated recall is complete.
REASON
Undeclared sulfites (1376 ppm) based on New York State Department of Agriculture and Markets sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
7,680 plastic tubs.
DISTRIBUTION
NY, NJ, MA, CT, VA, and FL.

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PRODUCT
Chinese Candy. Product of China. Net. Wt. 12 oz. 340 g. Serving Size 50 g. Servings per container: about 7. Barcode # 43719 12649. Recall # F-422-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Allied Imports, Inc., Brooklyn, NY, by letters dated February 26, 2003, and by press release on February 27, 2003. New York State initiated recall is complete.
REASON
The product contained undeclared sulfites based on New York State Department of Agriculture and Markets sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
2,500 - 12 oz. packages.
DISTRIBUTION
NY.

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PRODUCT
Golden Stream brand Island Crunch Mix, packaged in 8 oz. preprinted plastic stand up bag. Recall # F-423-3.
CODE
Best by dates between 100303 and 050504.
RECALLING FIRM/MANUFACTURER
Golden Stream Quality Foods Co., Inc. Fishers, IN, by press release on May 30, 2003, by telephone, and letter on June 3, 2003. Firm initiated recall is ongoing.
REASON
Product contains undeclared cashews.
VOLUME OF PRODUCT IN COMMERCE
14,920 cases (12 bags/case).
DISTRIBUTION
Nationwide.

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PRODUCT
Premium Sara Lee Butter Streusel Coffee Cake, packaged frozen in 11.5 oz cartons, 8 cartons per shipping case. Recall # F-424-3.
CODE
0409302915, 0409302916, 0409302917, and 0409302918.
RECALLING FIRM/MANUFACTURER
Sara Lee Bakery Group, Inc., Saint Louis, MO, by press release, and letters on March 28, 2003. Firm initiated recall is complete.
REASON
Butter Streusel Coffee Cake cartons may contain a different product, Pecan Coffee Cake (undeclared pecans).
VOLUME OF PRODUCT IN COMMERCE
49,592 cartons (6,199 cases).
DISTRIBUTION
Nationwide.

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PRODUCT
Smoked salmon in vacuum packed package labeled "Pacific Seafood Northwest Style Smoked Salmon." Product is of various weight packages, approximate 1/2 lb. packages to 1 lb. packages. Recall # F-425-3.
CODE
033121 073103 on orange sticker.
RECALLING FIRM/MANUFACTURER
Pacific Seafood Co., Inc., Clackamas, OR, by press release, telephone and letter on June 5, 2003. FDA initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
433.55 lbs.
DISTRIBUTION
WA, and OR.

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PRODUCT
Pacific Fresh Seafood Mix - a mixture of frozen Cuttlefish, Octopus, Cooked Mussels, Shrimp and Imitation Crab in a 1 lb plastic package. Recall # F-426-3.
CODE
02281, 02329, 02301, 02305, 02320, 02325, 03326, 02327, 02328, 02329, 02332, 02341, 03011, 03012, 03015, 03016, 03017, 03035, 03036, 03037, 03038, and 03039.
RECALLING FIRM/MANUFACTURER
Pacific Seafood Co., Inc., Clackamas, OR, by letter on April 21, 2003. FDA initiated recall is complete.
REASON
Seafood Mix does not list subingredients of imitation crab including egg white, fish, and wheat flour.
VOLUME OF PRODUCT IN COMMERCE
72,480 lbs (3624 cases).
DISTRIBUTION
OR, WA, CA, UT, KS, ID, TX, and NV.

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PRODUCT
Turkey Hill Dairy brand Cookies N Cream Ice Cream in half gallon containers. Recall # F-433-3.
CODE
13JAN04X.
RECALLING FIRM/MANUFACTURER
Turkey Hill Dairy, Inc., Conestoga, PA, by press release on March 28, 2003. Firm initiated recall is complete.
REASON
Ice cream was mispackaged and as a result, the product contained undeclared chocolate covered peanuts.
VOLUME OF PRODUCT IN COMMERCE
14,916 units.
DISTRIBUTION
MD and Washington, DC.

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PRODUCT
Chinese date (Dried Fruit), Net Wt. 150 g (5 oz), packaged in a heat-sealed, flexible foil-type bag. Product of China. Barcode # 921585 439945. Recall # F-435-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Mon Chong Loong Trading Corp., Maspeth, NY, by press release and letter dated December 6, 2002. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites (128 ppm) based on New York State Department of Agriculture and Markets sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
NY.

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PRODUCT
a) The Brownie Baker Gourmet Cookies Triple Chocolate Chip,
5.5 oz. Recall # F-444-3;
b) The Brownie Baker Gourmet Cookies Chocolate Chip
Brownie, 4 oz. Recall # F-445-3;
c) The Brownie Baker Gourmet Cookies Peanut Butter Brownie,
4 oz. Recall # F-446-3.
CODE
a) 170, 175, 176, 184, and 190;
b) 171, 178, 179, 184, 186, and 191;
c) 171, 178, 186, 189, and 191.
RECALLING FIRM/MANUFACTURER
The Brownie Baker, Inc., Fresno, CA, by telephone on July 15, 2002, and by letters on July 16, 2002. FDA initiated recall is complete.
REASON
Bakery products contained undeclared ingredients including nonfat milk powder and whey.
VOLUME OF PRODUCT IN COMMERCE
4,770 units.
DISTRIBUTION
CA, SC, NC, and MN.

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PRODUCT
Peregrina Cheese brand Queso Fresco, Fresh Cheese, sold in 14 oz. plastic containers. Recall # F-451-3.
CODE
Code 1049, (on grocery sticker), Plant # 36-8431.
RECALLING FIRM/MANUFACTURER
Peregrina Cheese Company, Brooklyn, NY, by by press release and telephone on April 25, 2003. New York State initiated recall is complete.
REASON
The cheese was contaminated with Listeria monocytogenes based on New York State Department of Agriculture and Markets sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
400 - 14 oz. units.
DISTRIBUTION
NY, and NJ.

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PRODUCT
Gold Chinese Products brand Dried Plum, Net Wt 142 g (5 oz) +/- 5 g, packaged in a flexible plastic bag. Barcode # 891139 000131. Product of China. Recall # F-452-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Golden Dynasty Trading, Inc., Brooklyn, NY, by press release and telephone on December 6, 2002. New York State initiated recall is complete.
REASON
Product contained sulfites (192 ppm) which were not not declared on labeling, and also contained the unapproved color Ponceau 4R (E124, Acid Red 18).
VOLUME OF PRODUCT IN COMMERCE
64 cases (50 packages per case).
DISTRIBUTION
NY, MA, CT, NC, GA, MO, VA, MD, and IL.

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PRODUCT
This dried fruit product is labeled mainly in Chinese and identified as "Preserved Mixed Plums", packaged in a flexible plastic bag, net wt 5.3 oz. (50g). Product of China. There are 48 - 5.3 oz. packages per case. Recall # F-453-3.
CODE
BEST BEFORE: 2003.03.13.
RECALLING FIRM/MANUFACTURER
Lion Pavilion Ltd., Brooklyn, NY, by telephone on August 9, 2002. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites (173 ppm) based on New York State Department of Agriculture and Markets analysis.
VOLUME OF PRODUCT IN COMMERCE
8 cases (48 - 5.3 oz. packages per case).
DISTRIBUTION
NY.

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PRODUCT
CORA brand Paprika, 4.25 oz. plastic jar with red cap. Recall # F-454-3.
CODE
All lots including 21002 and 21003, contained in a shipment received from Canada with invoice date of 4/14/03. Investigators observed some jars with illegible codes.
RECALLING FIRM/MANUFACTURER
Casa Imports, Inc., Utica, NY, by visits on June 11, 2003, and press release on June 12, 2003. FDA initiated recall is complete.
REASON
Product is contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
18 cases x 12 jars.
DISTRIBUTION
NY, and PA.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

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PRODUCT
Mint Meltaways Chocolate Candies. Sold as Pulakos Brand in 6 oz packages (plastic bags). Labeled as Pulakos 926 Chocolates. Recall # F-434-3.
CODE
Codes 2502 through 3652.
RECALLING FIRM/MANUFACTURER
Pulakos, Inc., Erie, PA, by telephone on December 31, 2002. New York State initiated recall is complete.
REASON
Products contained undeclared colors - FD&C; Yellow #5 and FD&C; Blue #1.
VOLUME OF PRODUCT IN COMMERCE
62 packages.
DISTRIBUTION
PA, and NY.

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PRODUCT
Product is not labeled in English and was identified as "Vegetables with Hot Oil", packed in 280-gram glass jars. Jars were labeled in Chinese with the Nutrition Facts Panel labeled in English. Recall # F-436-3.
CODE
Codes 2002-07-31 and 2002-11-15.
RECALLING FIRM/MANUFACTURER
Lion Pavilion Ltd., Brooklyn, NY, by press release and letters on March 10, 2003. New York State initiated recall is complete.
REASON
Product did not bear an ingredient statement in English and contained peanuts based on NYSDAM analysis. Peanuts were visible in the sauce.
VOLUME OF PRODUCT IN COMMERCE
300 cartons (12-280 gram jars per carton).
DISTRIBUTION
NY.

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PRODUCT
White Clover Honey, in glass bottles, packaged under the Dickinson's label (1.1 oz and 1.75 oz ), Ritz Carlton label (1.1 oz), and Atlanta Grill labels (1.1 oz); 72 bottles per case. ------ Dickenson's 1.1 oz and 1.75 oz bottles labeled in part, Dickenson's Pure Honey ** Net Wt ** Pure Clover Honey **.
The Ritz Carlton 1.1 oz bottles labeled in part, White Clover Honey ** U.S. Fancy ** ** Net Wt 1.1 oz **.
The Atlanta Grill 1.1 oz bottles labeled in part, White Clover Honey ** Net Wt 1.1 oz **.
Dickenson's 32 g bottles (Canadian) labeled in part, Dickenson's Money Miel ** 32g ** Product of U.S.A. ** #1 White Liquid **. Recall # F-443-3.
CODE
Dickenson's (1.1 oz) Lots: 72C11, 72E13, 72E14, 72F14, 72F17;
Dickenson's (1.75 oz) Lots: 72B26, 72E08;
Carlton Ritz (1.1 oz) Lots: 2049, 2133, 2184;
Atlanta Grill (1.1 oz) Lot: 2049.
Dickenson's (32 g bottles), Lots: 72C11, 72E13, 72F14 [these lots were distributed only in Canada].
RECALLING FIRM/MANUFACTURER
JM Smucker Co., Orrville, OH, by letter dated June 9, 2003. Firm initiated recall is ongoing.
REASON
The product is contaminated with chloramphenicol (0.3 - 1.7 ppb).
VOLUME OF PRODUCT IN COMMERCE
12,040 cases.
DISTRIBUTION
Nationwide and Canada.

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PRODUCT
a) The Brownie Baker Strawberry Cheesecake,
4.5 oz. Recall # F-447-3;
b) The Brownie Baker Cheesecake, 4.5 oz. Recall # F-448-3.
CODE
a) 171, 178, 179, 186, and 191;
b) 171, 178, 179, 183, 186, 189, and 191;
RECALLING FIRM/MANUFACTURER
The Brownie Baker, Inc., Fresno, CA, by telephone on July 15, 2002, and by letters on July 16, 2002. FDA initiated recall is complete.
REASON
The products contained undeclared ingredients including colors - FD&C; Yellow #5 and #6.
VOLUME OF PRODUCT IN COMMERCE
4,770 units.
DISTRIBUTION
CA, SC, NC, and MN.

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PRODUCT
Dried Octopus, Net Wt. 6 oz. (170 g.) Product of Japan. Product is packed in a clear, flexible plastic package. Barcode # 7 85165 10191. Recall # F-449-3
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
ADCO (USA) Inc., Brooklyn, NY, by press release and letters dated June 11, 2003. Florida State initiated recall is ongoing.
REASON
Product contained undeclared sulfites based on the Florida Department of Agriculture & Consumer Services' sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
80 cartons.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

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PRODUCT
Potato Salad/Egg, Mrs. Minnick's Home Style, in 10 lb waxed paper cartons. Recall # F-421-3.
CODE
Date code 5/7.
RECALLING FIRM/MANUFACTURER
Mrs. Minnick's Salads, Inc., Baltimore, MD, by fax dated May 12, 2003. Firm initiated recall is complete.
REASON
The product did not list subingredients of mayonnaise including egg yolks.
VOLUME OF PRODUCT IN COMMERCE
75 containers.
DISTRIBUTION
MD, and NJ.

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PRODUCT
a) Chilled Simply Apple Juice. Recall # F-441-3;
b) Chilled Simply Apple Cider. Recall # F-442-3.
CODE
a) Best Before Jan 25 XX:XX LB23 Apple,
Best Before Jan 26 XX:XX LB23 Apple,
Best Before Feb 10 XX:XX LB23 Apple;
b) Best Before Jan 26 XX:XX LB23 Cider,
Best Before Feb 10 XX:XX LB23 Cider,
Best Before Feb 11 XX:XX LB23 Cider.
RECALLING FIRM/MANUFACTURER
Coca Cola Foods, Houston, TX, by letter on January 9, 2003. Pennsylvania State initiated recall is complete.
REASON
Mold was present in this product.
VOLUME OF PRODUCT IN COMMERCE
6,155 cases.
DISTRIBUTION
PA, NY, and CT.

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PRODUCT
Ardmore Farms Select Grove Guava Nectar Juice Drink, Pasteurized, Refrigerated, packaged in 64 fl. Oz. (2 qt) paper cartons. Recall # F-450-3.
CODE
Best By Code: May 23, 2003.
RECALLING FIRM/MANUFACTURER
Country Pure Foods, Inc., Akron, OH, by telephone and letter on April 2, 2003 and April 3, 2003. Firm initiated recall is complete.
REASON
Juice drinks are spoiled due to yeast contamination.
VOLUME OF PRODUCT IN COMMERCE
19,000 half-gallon containers.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
a) LIPITOR Tablets (ATORVASTATIN CALCIUM) 10 mg, 90
Tablets, Rx only. Recall # D-268-3;
b) LIPITOR Tablets (ATORVASTATIN CALCIUM) 20 mg, 90
Tablets, Rx only. Recall # D-269-3.
CODE
a) Lot 12912V, Exp. 10/04; Lot 12912V 1, Exp. 10/04;
Lot 12912V 2, Exp. 10/04; Lot 12912V 3, Exp. 10/04;
Lot 04132V 1, Exp. 01/04; Lot 04132V 2, Exp. 01/04;
Lot 04132V 3, Exp. 01/04; Lot 04132V 4, Exp. 01/04;
Lot 04132V 5, Exp. 01/04; Lot 04132V 6, Exp. 01/04;
Lot 04132V 7, Exp. 01/04; Lot 10772V 1, Exp. 05/04;
Lot 10772U 1, Exp. 05/04; Lot 12542V 1, Exp. 05/04;
Lot 2072V 1, Exp. 09/04; Lot 20722V 1, Exp. 09/04;
Lot 20722V 2, Exp. 09/04; Lot 20722V 3, Exp. 09/04;
Lot 20722V 4, Exp. 09/04; Lot 16942V, Exp. 09/04;
Lot 16942V 1, Exp. 09/04; Lot 16942V 2, Exp. 09/04;
Lot 16942V 3, Exp. 09/04; Lot 16942V 4, Exp. 09/04;
Lot 437023 1, Exp. 02/05;
b) Lot 027049D, Exp. 02/04; Lot D27048 1, Exp. 02/04;
Lot D27049 1, Exp. 02/04; Lot 511022 1, Exp. 06/04;
Lot 511022 2, Exp. 06/04; Lot 0511022 3, Exp. 06/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Albers Medical Distributors, Kansas City, MO, by letters on May 22, 2003, June 4, 2003 and June 9, 2003.
Manufacturer: Unknown at this time. Firm initiated recall is ongoing.
REASON
Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE
Approx 174,955/90-tablet bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Amiloride Hydrochloride Tablets, USP, 5 mg, 100 tablet bottles, Rx only. Recall # D-277-3.
CODE
Lot 035607; Expiration Date: 12/2004.
RECALLING FIRM/MANUFACTURER
Par Pharmaceutical, Spring Valley, NY, by letters on May 30, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; Bottle labeled as containing 5 mg Amiloride Hydrochloride tablets actually contains Minoxidil 2.5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
4,821/100 count bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Levoxyl Tablets,(Levothyroxine Sodium Tablets, USP), 112 mcg, 1000 tablet bottles, Rx only. Recall # D-280-3.
CODE
Lot No. 7941, Exp. Date 05/2004.
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals, Inc., Bristol, TN, by letters on June 18, 2003. Firm initiated recall is ongoing.
REASON
Tablet mixup; bottles labeled to contain Levoxyl 112 mcg were found to contain Levoxyl and Soloxine 0.2 mg tablets (Vet/Animal brand-Levothyroxine).
VOLUME OF PRODUCT IN COMMERCE
2,639 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Premarin 0.625 mg Tablets, U.D. 100's (conjugated estrogens tablets, USP) Rx only. Recall # D-267-3.
CODE
Lot Number IJ00170.
RECALLING FIRM/MANUFACTURER
Amerisource Health Services Corp., Columbus, OH, by letters on June 2, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure (by manufacturer Wyeth)
VOLUME OF PRODUCT IN COMMERCE
5 cartons - 100 unit dose tablets.
DISTRIBUTION
Nationwide.

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PRODUCT
Levsin Elixir (hyoscyamine sulfate elixir USP), 0.125 mg/mL 473mL (l pint) syrup, Rx only. Recall # D-270-3.
CODE
Lot 20920.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schwarz Pharma Manufacturing, Seymour, IN, by telephone on April 7, 2003 and by letters on May 14, 2003.
Manufacturer: Elge Inc., Rosenberg, TX. Firm initiated recall is ongoing.
REASON
Mislabeled front label incorrectly states the product strength as 0.125 mg/mL rather than correctly as 0.125 mg/5 mL.
VOLUME OF PRODUCT IN COMMERCE
393 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
EXTRA STRENGTH PAIN RELIEVER without aspirin, (Acetaminophen) 500 mg, 1000 tablet bottles, Pain Reliever/Fever Reducer. Recall # D-278-3.
CODE
Lot # 310715.
RECALLING FIRM/MANUFACTURER
Magno Humphries, Inc., Tigard, OR, by letter on November 14, 2002. Firm initiated recall is complete.
REASON
Microbial contamination; product contains mold.
VOLUME OF PRODUCT IN COMMERCE
1,200 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Decolorized IODINE TINCTURE, (Alcohol 41-45%, Iodine 3%, Potassium Iodide 1.5%), 1 FLUID OUNCE bottle, POISON. Recall # D-281-3.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Denison Pharmaceuticals, Inc., Pawtucket, RI, by telephone on May 14, 2003. Firm initiated recall is complete.
REASON
Mislabeled; product contains undeclared ammonium hydroxide.
VOLUME OF PRODUCT IN COMMERCE
794 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
0.9% Sodium Chloride Injection, USP, 100 mL, ADDS Unit Single-dose container, For I.V. use, Rx only. Recall # D-283-3.
CODE
Lot Numbers: 01-262-JT, 02-179-JT, 02-236-JT, 03-012-JT, 03-234-JT, 03-138-JT, 04-086-JT, 04-130-JT, 04-137-JT, and 05-072-JT.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letters on June 23, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; incorrect bar code on overwrap of the product.
VOLUME OF PRODUCT IN COMMERCE
980,592 bags.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: HUMAN TISSUE MANDATORY RECALLS

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PRODUCT
Human Tissues for transplantation. Recall # B-1309-3.
CODE
a) Non-Valve Cardiac Tissue;
b) Ortho Tissue;
c) Vein Tissue.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated August 22. 2002, August 27-28, 2002, October 1, 2002, November 7, 2002, or January 27, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, for which the firm failed to take adequate corrective measures to address possible infectious disease contamination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 739 units;
b) 4,201 units;
c) 2,973 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I

_______________________________
PRODUCT
Human Tissue for transplantation. Recall # B-0948-3.
CODE
Saphenous Vein Donor #55698, Serial number 6160794.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter on or about March 12, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, collected from a donor whose companion sample, from a different site, was positive for microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Source Plasma. Recall # B-1078-3.
CODE
0090596020, 0090595738, 0090595384, 0090594996, 0090593998, 0090593747, 0090587411, 0090587175, 0090586834, 0090586584, 0090586206, 0090585760, 0090585310, 0090585079, 0090582887, 0090581850, 0090581641, 0090581219, 0090580795, 0090580287, 0090580065, 0090579480, 0090578141, 0090577937, 0090577512, 0090576982, 0090576679, 0090576383, 0090576109, 0090575745, 0090575478, 0090575103, 0090574796, 37163808, 37162825, 37161811, 37160852, 37157357, 30481220, 41057346, 41054963, 41053188, 41052129, 41044476, 41042311, 41041086, 28539292, 28537311, 28535645, 28534365,
29560035, 29557981, 24785839, 24782807, 24781428, 24647755, 24646260.
RECALLING FIRM/MANUFACTURER
NABI Biomedical Center, Scranton, PA, by facsimile dated May 13, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had body piercing within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units.
DISTRIBUTION
CA, and Austria.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1284-3.
CODE
Unit 50LG80935.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone on October 21, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of red cells that was implicated in a transfusion reaction and found to be contaminated with Streptococcus oralis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1303-3;
b) Platelets. Recall # B-1304-3;
c) Fresh Frozen Plasma. Recall # B-1305-3.
CODE
a), b), and c) Unit 7827826.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter dated August 28, 2001. Firm Initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1306-3.
CODE
Units 5329576, 7587566, and 5300890 (split unit).
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter dated July 18, 2001. Firm Initiated recall is complete.
REASON
Blood products, which did not have quality control testing for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1307-3.
CODE
Unit 7892624.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter dated July 5, 2001. Firm Initiated recall is complete.
REASON
Blood products, collected from a donor who affirmatively answered a medical history question related to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1342-3;
b) Fresh Frozen Plasma. Recall # B-1343-3.
CODE
a), and b) Unit number 5077836.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME, by telephone on December 13, 2002, and by letter dated December 17, 2002. Firm initiated recall is complete
REASON
Blood products, that tested repeatedly reactive for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ME.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1344-3;
b) Recovered Plasma. Recall # B-1345-3.
CODE
a), an b) Unit number 4349455.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on August 9, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, and NJ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1346-3;
b) Cryoprecipitated. Recall # B-1347-3.
CODE
a), and b) Unit number 4179284.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on December 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and NJ.

_______________________________
PRODUCT
Platelets. Recall # B-1349-3;
Fresh Frozen Plasma. Recall # B-1350-3.
CODE
a) Unit numbers 38LC18763, 38H54665, 38H54672, 38FC66777,
38LC13501, 38H52839, 38H52015, 38K99105 and 38FC57207;
b) Unit numbers 38L64002, 38H54665, 38H54672, 38H52839,
38FK14212, 38LC12671, 38H52015, 38FH08706, 38FC61062 and
38K82831.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter on April 2, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 9 units;
b) 10 units.
DISTRIBUTION
IN, MT, and MS.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1351-3.
CODE
Unit number 38P80509.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on March 20, 2003. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1352-3;
b) Recovered Plasma. Recall # B-1353-3.
CODE
a) and b) Unit number 38FC90836.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter on January 10, 2003, and by facsimile on January 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN, and CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1354-3;
b) Platelets. Recall # B-1355-3;
c) Fresh Frozen Plasma. Recall # B-1356-3.
CODE
a), b), and c) Unit number 1892984.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 25 and 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1357-3;
b) Fresh Frozen Plasma. Recall # B-1358-3.
CODE
a) and b) Unit number 2356275.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on November 5 and 19, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and WI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1360-3;
b) Cryoprecipitated AHF, Pooled. Recall # B-1361-3;
c) Plasma, Cryoprecipitate Reduced. Recall # B-1362-3.
CODE
a) and c) Unit number 2348972;
b) Unit number 4018697.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 24, 2002, and February 18, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units; 1 pool.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1363-3;
b) Recovered Plasma. Recall # B-1364-3.
CODE
a) and b) Unit number 2336335.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 8, 9, and 14, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and FL.

_______________________________
PRODUCT
Human Tissue for Transplantation, Pulmonic Valve. Recall # B-1365-3.
CODE
Unit number 202683.
RECALLING FIRM/MANUFACTURER
Alabama Tissue Center, Inc., Birmingham, AL, by telephone on May 5, 2003. Firm initiated recall is complete.
REASON
Human tissue was inadequately tested for infectious disease in that the blood sample used for testing may have been hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1367-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1368-3;
c) Platelets. Recall # B-1369-3;
d) Cryoprecipitated AHF. Recall # B-1370-3;
e) Source Leukocytes. Recall # B-1371-3;
f) Recovered Plasma. Recall # B-1372-3.
CODE
a) Unit numbers 3358116, 3336687, 3296389, 3262624,
3228118, 3124127, 3099634, 3055028, 3022898, 2987487,
2855967, 2819888, and 2765485;
b) Unit number 3188732;
c) Unit numbers 3336687, 3296389, 3228118, 3124127,
2987487, 2855967, 2819888, and 2765485;
d) Unit number 3022898;
e) Unit numbers 3406252, 3358116, 3336687, 3262624,
3228118, 3124127, 3099634, 3055028, 3022898, 2987487,
2855967, 2819888, and 2765485;
f) Unit numbers 3358116, 3336687, 3296389, 3228118,
3099634, 2819888, 3262624, 3188732, 3124127, 3055028,
2855967, and 2765485.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on July 30, 1998. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 13 units;
b) 1 unit;
c) 8 units;
d) 1 unit;
e) 13 units;
f) 12 units.
DISTRIBUTION
CA, TX, MI, NY, NJ, FL, NE, WA, and PR.

_______________________________
PRODUCT
Human Tissue for Transplantation, Pulmonic Valve. Recall # B-1373-3.
CODE
Unit number 2502656.
RECALLING FIRM/MANUFACTURER
Alabama Tissue Center, Inc., Birmingham, AL, by telephone on May 7, 2003. Firm initiated recall is complete.
REASON
Human tissue was procured from an unsuitable donor due to a possible familial history of Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1389-3;
b) Recovered Plasma. Recall # B-1390-3.
CODE
a) and b) Unit numbers 27GG17859 and 27GG16746.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter and facsimile on December 18, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
PA, and CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1392-3;
b) Recovered Plasma. Recalled # B-1393-3.
CODE
a), and b) Unit number 4128753.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on July 9, 2002.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and NJ.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1394-3.
CODE
Unit number 4368681.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on August 16, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1395-3;
b) Platelets. Recall # B-1396-3.
CODE
a) Unit numbers 34026249 and 32022579;
b) Unit number 34026249.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on February 28, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1399-3.
CODE
Unit number 6812013.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on February 28, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1406-3.
CODE
Unit numbers 11020334, 31028492, and 31028500.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on February 6, 2001. Firm initiated recall is complete.
REASON
Blood products that were labeled as Red Blood Cells, Leukocytes Reduced, but had not been leukocyte reduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1408-3;
b) Cryoprecipitated AHF. Recall # B-1409-3;
c) Recovered Plasma. Recall # B-1410-3.
CODE
a), b), and c) Unit number 21GE31093.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on March 8, 2002, by electronic mail on March 12, 2002, and by letters on March 15, 2002, and May 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OR, CA, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1411-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1412-3;
c) Plasma. Recall # B-1413-3;
d) Recovered Plasma. Recall # B-1414-3.
CODE
a) and c) Unit number 21GW24094;
b) and d) Unit numbers 21GW33411 and 21GW32322.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by electronic mail on January 23, 2002, and by letter on January 28, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
OR, CA, and WA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRO DUCT
Platelets. Recall # B-1302-3.
CODE
Unit number 7841543.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 29, 2001. Firm initiated recall is complete.
REASON
Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1308-3.
CODE
Unit 7892624.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter dated July 5, 2001. Firm Initiated recall is complete.
REASON
Blood products, collected from a donor who affirmatively answered a medical history question related to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1310-3;
b) Cryoprecipitated AHF. Recall # B-1311-3;
c) Recovered Plasma. Recall # B-1312-3.
CODE
a), b), and c) Unit number 7823699.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated October 19, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.

_______________________________
PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced.
Recall B-1313-3;
b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall # B1314-2.
CODE
a) Units # 21KP31384, 21KP31385;
b) Unit # 21KP31387.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, by telephone on March 25, 2002, and by letter dated March 26, 2002. Firm initiated recall is complete.
REASON
Platelets, labeled with an incorrect volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OR, and CA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1348-3.
CODE
Unit number 4179284.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on December 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and NJ.

_______________________________
PRODUCT
Platelets for Further Manufacture. Recall # B-1359-3.
CODE
Unit number 2356275.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on November 5 and 19, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and WI.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1366-3.
CODE
Unit numbers 0000010 and 0000012.
RECALLING FIRM/MANUFACTURER
The Extracorporeal Alliance, L.L.C., Lansing, MI, by telephone on November 20, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for viral markers due to the use of expired blood sample tubes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1391-3.
CODE
Unit numbers 8237532, 8237542, and 6811952.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on March 19, 2003. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IN.
___________________________
PRODUCT
Red Blood Cells. Recall # B-1397-3.
CODE
Unit numbers 6839759 and 6839765.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by telephone on February 4, 2003. Firm initiated recall is complete.
REASON
Blood product, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
___________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1400-3.
CODE
Unit number 6814186.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on January 28, 2002. Firm initiated recall is complete.
REASON
Platelets, not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

___________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1402-3.
CODE
Unit numbers 6810493, and 6810498.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on February 28, 2002. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested for white blood cell count within the time frames required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
___________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1403-3.
CODE
Unit number 10026857.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on August 23, 2001. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but were not tested for white blood cell count within the time frames required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
___________________________
PRODUCT
a) Red Blood Cells. Recall # B-1404-3;
b) Recovered Plasma. Recall # B-1405-3.
CODE
a), and b) Unit number 30017971.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on February 16, 2001, and by facsimile on February 20, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and Switzerland.
___________________________
PRODUCT
Red Blood Cells. Recall # B-1407-3.
CODE
Unit number 12011334.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by telephone on February 3, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of a chronic ulcerative condition, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
A) Vented and Non-Vented Burette I.V. Gravity Feed
Administration Sets; sterile, Rx, single use devices;
15 different sets listed. Recall # Z-0955-03;
a) Latex-Free 250 mL Burette Set, Vented, 77 Inch
Soluset;
b) Latex-Free 100 mL Burette Set, Vented, 77 Inch
Soluset;
c) Latex-Free 150 mL Burette Set, Vented, 77 Inch;
d) Latex-Free 150 mL Burette Set, Vented, 100 Inch;
e) LifeShield Latex-Free 150 mL Burette Set, Vented, 100
Inch;
f) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 77 Inch;
g) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 110 Inch;
h) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 77 Inch;
i) LifeShield Latex-Free Inline Burette Set 150 mL,
Nonvented;
j) 150 mL Burette Set, Nonvented, 77 Inch;
k) Latex-Free 150 mL Burette Set, Nonvented, 77 Inch;
l) LifeShield Latex-Free 150 mL Burette Set, Vented, 108
Inch;
m) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 77 Inch;
n) Venisystems Soluset 150 x 15;
o) LifeShield Latex-Free 150 mL Burette Set, Vented,
Convertible Pin, 77 Inch;
B) I.V. Extension Sets; sterile, Rx, single use devices;
22 different sets listed in the code information section
below. Recall # Z-0956-03;
a) LifeShield Latex-Free Pediatric Extension Set, 10.5
Inch;
b) LifeShield Latex-Free Pressure Activated Valve
Extension Set with Locking Spin Collar "T";
c) LifeShield Latex-Free VeniLoop Connector;
d) LifeShield Latex-Free Microbore Extension Set,
7 Inch;
e) LifeShield Latex-Free Microbore Extension Set;
f) LifeShield Latex-Free Microbore Extension Set with
Clave, Locking Spin Collar "T" and Prepierced
Injection Site;
g) LifeShield Latex-Free Macrobore Extension Set,
7 Inch;
h) LifeShield Latex-Free Microbore Extension Set,
7 Inch;
i) LifeShield Latex-Free Macrobore Extension Set;
j) LifeShield Latex-Free Microbore Extension Set;
k) LifeShield Latex-Free Microbore Extension Set INT,
6 Inch;
l) LifeShield Latex-Free Tri-Leg Microbore Extension
Set;
m) LifeShield Latex-Free Tri-Leg Extension Set;
n) LifeShield Latex-Free Microbore Extension Set;
o) LifeShield Latex-Free Extension Set, 6 Inch;
p) Sterile Latex-Free Microbore Extension Set;
q) Sterile Latex-Free Microbore Extension Set;
r) Microbore Extension Set;
s) LifeShield Latex-Free Macrobore Extension Set, 46
Inch;
t) LifeShield Latex-Free Y-Type Connecting Set, 9 Inch;
u) LifeShield Latex-Free Macrobore Extension Set;
v) LifeShield Latex-Free Microbore Extension Set, 19
Inch;
Please Note: items p, q & r (list 191700204, 191700404
and 191700415) were packaged in kits with Sporanox
Injection distributed by Ortho Biotech Products,
Raritan, NJ.
C) Primary I.V. Gravity Administration Sets; sterile, Rx,
L 60064 USA; 95 different sets listed.
Recall # Z-0957-03;
a) Latex-Free Primary I.V. Set, Nonvented, 100 Inch;
b) Latex-Free Primary I.V. Set, Nonvented, 78 Inch;
c) Latex-Free Primary I.V. Set, Nonvented, 100 Inch;
d) Latex-Free Primary I.V. Set, Convertible Pin,
70 Inch;
e) Primary I.V. Set, Nonvented, 72 Inch;
f) Latex-Free Primary I.V. Set, Nonvented, 78 Inch;
g) Primary I.V. Set, Nonvented, 78 Inch;
h) Latex-Free Primary I.V. Set, Nonvented, 80 Inch;
i) Latex-Free Y-Type Primary I.V. Set, Nonvented,
86 Inch;
j) Latex-Free Primary I.V. Set, Vented, 78 Inch;
k) Latex-Free Primary I.V. Set, Convertible Pin,
78 Inch;
l) Latex-Free Primary I.V. Set, 78 Inch;
Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch;
Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch;
o) Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch;
Latex-Free Cardiac Catheterization Set, Nonvented,
67 Inch;
q) Latex-Free Manifold III with Secure Lock;
r) Latex-Free Primary I.V. Set, Nonvented, 106 Inch,
s) Latex-Free Primary I.V. Set, Convertible Pin, 106
Inch;
t) Primary I.V. Set, Vented, 72 Inch;
u) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
v) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 106 Inch;
w) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 106 Inch;
x) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
y) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 70 Inch;
z) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch;
aa) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 78 Inch;
bb) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch;
cc) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 78 Inch;
dd) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch;
ee) Latex-Free Primary I.V. Set, Convertible Pin, 80
Inch;
ff) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
gg) LifeShield Latex-Free Primary I.V. Set, Nonvented,
100 Inch;
hh) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch;
ii) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch;
jj) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch;
kk) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 70 Inch;
ll) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
mm) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
nn) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
oo) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
pp) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
qq) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
rr) LifeShield Latex-Free Primary I.V. Set, Nonvented,
105 Inch;
ss) Latex-Free Primary I.V. Set, Convertible Pin, 112
Inch;
tt) LifeShield Latex-Free Primary I.V. Set, Nonvented,
110 Inch;
uu) Latex-Free Fat Emulsion I.V. Set, Convertible Pin,
110 Inch;
vv) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
ww) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
xx) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
yy) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 110 Inch;
zz) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch;
aaa) Primary I.V. Set, Nonvented, 72 Inch;
bbb) Latex-Free Primary I.V. Set, Convertible Pin, 84
Inch;
ccc) Primary I.V. Set, Nonvented, 93 Inch;
ddd) Latex-Free Primary I.V. Set, Convertible Pin, 78
Inch;
eee) Latex-Free Primary I.V. Set, Nonvented, 78 Inch;
fff) Latex-Free Primary I.V. Set, Convertible Pin,
83 Inch;
ggg) LifeShield Latex-Free Y-Type Anesthesia I.V. Set,
Nonvented, 130 Inch;
hhh) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 135 Inch;
iii) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Piercing Pin, 112 Inch;
jjj) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 112 Inch;
kkk) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 111 Inch;
lll) LifeShield Latex-Free Primary I.V. Set, Nonvented,
105 Inch;
mmm) LifeShield Latex-Free Prim. I.V. Set, Convertible
Pin, 110 Inch;
nnn) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 124 Inch;
ooo) LifeShield Latex-Free Primary I.V. Set with
Convertible Pin;
ppp) LifeShield Latex-Free Primary Piggyback I.V. Set,
Convertible Pin;
qqq) LifeShield Latex-Free Primary I.V. Set, Convertible
Piercing Pin, 147 Inch;
rrr) Latex-Free Primary I.V. Set, Convertible Pin, 82
Inch;
sss) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 83 Inch;
ttt) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 101 Inch;
uuu) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 107 Inch;
vvv) LifeShield Latex-Free Primary I.V. Set, Nonvented,
124 Inch;
zzz) LifeShield Latex-Free Primary I.V. Set, Nonvented,
110 Inch;
aaaa) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 141 Inch;
bbbb) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 126 Inch;
cccc) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 112 Inch;
dddd) LifeShield Latex-Free Primary I.V. Set, Nonvented,
127 Inch;
eeee) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 112 Inch;
ffff) Latex-Free Primary I.V. Set, Convertible Pin,
83 Inch;
gggg) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 111 Inch;
hhhh) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 104 Inch;
iiii) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 138 Inch;
jjjj) LifeShield Latex-Free Primary I.V. Set, Nonvented,
102 Inch;
kkkk) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 136 Inch;
llll) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 136 Inch;
mmmm) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 109 Inch;
nnnn) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 125 Inch;
oooo) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 80 Inch,;
pppp) Latex-Free Primary I.V. Set, Convertible Pin, 100
Inch with 2 Injection Sites, Microdrip;
qqqq) LifeShield Latex-Free Prim. I.V. Set, Convertible
Pin, 110 Inch.
Please note, item k, list 018810458, lot 910824W, was
also case packed with Liposyn II 20%, list 09793-04-03,
lot 94533DF and list 09792-04-02, lot 92522DF.
D) I.V. Pump Sets with Cassettes for use with Abbott Plum
Series and Lifecare Infusion Pumps; sterile, Rx, single
use devices; 86 different sets listed.
Recall # Z-0958-03;
a) LifeShield Latex-Free Primary I.V. Pump Set with
Distal Microbore Patient Line, Convertible Pin, 110
Inch;
b) Latex-Free Enteral PlumSet, Vented, 98 Inch;
c) Latex-Free Enteral PlumSet, Vented, 98 Inch;
d) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
e) LifeShield Latex-Free Secondary I.V. PlumSet,
Convertible Pin, 32 Inch;
f) LifeShield Latex-Free High-Pressure Filter Primary
I.V. PlumSet, Convertible Pin, 112 Inch;
g) LifeShield Latex-Free High-Pressure Filter Primary
I.V. PlumSet, Convertible Pin, 112 Inch
h) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch;
Latex-Free Primary I.V. PlumSet -OL, Convertible Pin;
Lifeshield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
Latex-Free, Primary I.V. Plumset - OL, Convertible
Pin, 104 Inch;
LifeShield Latex-Free Microdrip Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
Latex-Free Soluset 150 mL Burette I.V. Pump Set,
Vented, 114 Inch;
Latex-Free Nitroglycerin Primary I.V. Pump Set,
Convertible Pin, 107 Inch;
p) LifeShield Latex-Free Microdrip Nitroglycerin
PlumSet, Convertible Pin, 107 Inch;
q) LifeShield Latex-Free Microdrip Nitroglycerine
PlumSet, Convertible Pin;
r) Latex-Free Primary I.V. Pump Set, Convertible Pin,
105 Inch;
s) Latex-Free Primary I.V. PlumSet, Convertible Pin, 107
Inch;
t) LifeShield Latex-Free Microdrip Soluset 50 mL Burette
PlumSet, Convertible Pin, 105 Inch;
u) Latex-Free Enteral PlumSet with Integral Container,
Nonvented, 105 Inch;
v) Latex-Free Microdrip Primary I.V. Micro Pump Set,
Vented, 102 Inch;
w) Latex-Free Soluset Microdrip 150 mL Burette Micro Pump
Set, Vented, 124 Inch;
x) Latex-Free Specialty I.V. Pump Set-HB, Convertible
Pin, 105 Inch;
y) LifeShield Latex-Free HEMA Blood PlumSet, Nonvented,
110 Inch;
z) LifeShield Latex-Free Hemoset 100 mL Burette I.V.
PlumSet, Nonvented, 105 Inch;
aa) Latex-Free Primary I.V. PlumSet, Nonvented, 112 Inch;
bb) LifeShield Latex-Free Secondary I.V. PlumSet,
Convertible Pin, 18 Inch;
cc) LifeShield Latex-Free Primary I.V. PlumSet,
Nonvented, 104 Inch
dd) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
ee) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
ff) Latex-Free Primary I.V. Pump Set, Convertible Pin,
110 Inch;
gg) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
hh) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 122 Inch;
ii) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
jj) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 105 Inch;
kk) Latex-Free Soluset 150 mL Burette PlumSet,
Convertible Pin, 114 Inch;
ll) LifeShield Latex-Free Microdrip Soluset 150 mL
Burette PlumSet, Convertible Pin, 124 Inch;
mm) LifeShield Latex-Free HEMOSET, 100 mL Burette I.V.
PlumSet, Nonvented, 141 Inch;
nn) Latex-Free Secondary I.V. PlumSet, Convertible Pin,
18 Inch;
oo) Latex-Free Nitroglycerin PlumSet, Convertible Pin,
107 Inch;
pp) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
qq) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
rr) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 139 Inch;
ss) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 112 Inch
tt) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
uu) LifeShield Latex-Free Microdrip Soluset
150 mL Burette PlumSet, Convertible Pin, 124 Inch;
vv) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 139 Inch;
ww) Latex-Free Microdrip Soluset 150 mL Burette Pump Set,
Convertible Piercing Pin, 124 Inch;
xx) LifeShield Latex-Free Microdrip Soluset 150 mL
Burette PlumSet, Convertible Pin, 124 Inch;
yy) LifeShield Latex-Free Soluset 150 mL Burette I.V.
PlumSet, Convertible Pin, 114 Inch;
zz) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 139 Inch;
aaa) Latex-Free Nitroglycerin Primary I.V. Pump Set,
Convertible Pin, 110 Inch;
bbb) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
ccc) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
ddd) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch;
eee) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch;
fff) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch;
ggg) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 122 Inch;
hhh) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
iii) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
jjj) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch;
kkk) LifeShield Latex-Free Fat Emulsion I.V. PlumSet,
Convertible Pin, 104 Inch;
lll) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 112 Inch;
mmm) LifeShield Latex-Free 150 mL Burette PlumSet,
Convertible Pin, 114 Inch;
nnn) LifeShield Latex-Free GemStar Primary Piggyback Pump
Set-SL, Convertible Pin, 110 Inch;
ooo) Latex-Free GemStar Primary Piggyback I.V. Pump Set-
SL;
ppp) Latex-Free Enteral PlumSet, Nonvented, 98 Inch;
qqq) Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch;
rrr) LifeShield Latex-Free Primary I.V. PlumSet,
Nonvented, 113 Inch;
sss) LifeShield Latex-Free Nitroglycerin Primary I.V.
PlumSet, Convertible Pin, 107 Inch;
ttt) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 118 Inch;
uuu) LifeShield Latex-Free Primary I.V. Plumset,
Convertible Pin, 104 Inch;
vvv) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 124 Inch;
www) LifeShield Latex-Free 50 mL Burette PlumSet,
Convertible Pin, 107 Inch;
aaaa) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 135 Inch;
bbbb) LifeShield Latex-Free Microdrip Soluset 100 mL
Burette PlumSet, Convertible Pin, 121 1/2 Inch;
cccc) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 103 Inch;
dddd) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 110 Inch;
eeee) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 108 Inch;
ffff) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 137 Inch;
gggg) LifeShield Latex-Free Soluset 100 mL Burette
PlumSet, Convertible Pin, 121 Inch;
hhhh) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch;
E) Secondary I.V. Gravity Feed Sets; sterile, Rx, single
use devices; 15 different sets listed.
Recall # Z-0959-03;
a) Latex-Free Secondary I.V. Set, Convertible Pin, 32
Inch;
b) Latex-Free Secondary I.V. Set, Nonvented, 32 Inch;
c) Latex-Free Secondary I.V. Set, Convertible Pin,
35 Inch;
d) Latex-Free Secondary I.V. Set with Convertible Pin,
32 Inch;
e) Latex-Free Secondary I.V. Set, Nonvented, 35 Inch;
f) Latex-Free Midlength Secondary I.V. Set, 40 Inch;
g) LifeShield Latex-Free Secondary I.V. Set, Nonvented,
32 Inch;
h) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch;
i) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch;
j) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch;
k) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch;
l) ColorGard Latex-Free Midlength Secondary I.V. Set,
Convertible Pin, 40 Inch;
m) ColorGard Latex-Free Midlength Secondary I.V. Set,
Convertible Pin, 40 Inch;
n) ColorGard Latex-Free Midlength Secondary I.V. Set,
Convertible Pin, 40 Inch;
o) Latex-Free Midlength Secondary I.V. Set, Convertible
Pin, 40 Inch.
CODE
A) a) Latex-Free 250 mL Burette Set, Vented, 77 Inch
Soluset, list 017170402, lot 88006DT;
b) Latex-Free 100 mL Burette Set, Vented, 77 Inch
Soluset, list 017260402, lot 88100HG;
c) Latex-Free 150 mL Burette Set, Vented, 77 Inch,
list 018820468, lot 921495H;
d) Latex-Free 150 mL Burette Set, Vented, 100 Inch,
list 066460401, lot 911755H;
e) LifeShield Latex-Free 150 mL Burette Set, Vented, 100
Inch, list 113980401, lots 88073HG, 90014HG;
f) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 77 Inch, list 119640402, lots 88070HG, 88139HG,
89064HG, 90008HG, 921105H, 951025H;
g) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 110 Inch, list 120720401, lot 90015HG;
h) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 77 Inch, list 123410401, lot 88081HG;
i) LifeShield Latex-Free Inline Burette Set 150 mL,
Nonvented, list 124250401, lots 85030HG, 88009HG,
88055HG, 910745H, 930175H;
j) 150 mL Burette Set, Nonvented, 77 Inch,
list 153630468, lot 931255H;
k) Latex-Free 150 mL Burette Set, Nonvented, 77 Inch,
list 153800468, lot 88068HG;
l) LifeShield Latex-Free 150 mL Burette Set, Vented, 108
Inch, list 191890401, lot 89055HG;
m) LifeShield Latex-Free 150 mL Burette Set, Convertible
Pin, 77 Inch, list 192080401, lots 87017HG, 87125HG,
891765H, 941045H, 961595H;
n) Venisystems Soluset 150 x 15, list 0E4031301,
lot 86100HG;
o) LifeShield Latex-Free 150 mL Burette Set, Vented,
Convertible Pin, 77 Inch, list 117440401, lots
88106HG, 930145H, 961465H;
B) a) LifeShield Latex-Free Pediatric Extension Set, 10.5
Inch, list 026940468, lots 910085H, 940405H;
b) LifeShield Latex-Free Pressure Activated Valve
Extension Set with Locking Spin Collar "T",
list 047300402, lots 87080NS, 89099HG;
c) LifeShield Latex-Free VeniLoop Connector,
list 114810401, lot 891085H;
d) LifeShield Latex-Free Microbore Extension Set, 7
Inch, list 119570402, lots 88057NS, 88103NS;
e) LifeShield Latex-Free Microbore Extension Set,
list 119580401, lots 87084NS, 88056NS, 88078NS,
89088NS, 89143NS, 89181NS;
f) LifeShield Latex-Free Microbore Extension Set with
Clave, Locking Spin Collar "T" and Prepierced
Injection Site, list 120530401, lots 86107NS,
87126NS, 88125NS;
g) LifeShield Latex-Free Macrobore Extension Set, 7
88030HG, 88031HG, 891045H, 891875H, 891885H, 900165H,
900175H, 901015H, 910235H, 911485H, 920225H, 920785H,
921485H, 930425H, 930925H, 931205H, 940835H;
h) LifeShield Latex-Free Microbore Extension Set, 7
Inch, list 121130402, lot 87127NS;
i) LifeShield Latex-Free Macrobore Extension Set,
list 123120401, lots 891095H, 910555H, 960775H;
j) LifeShield Latex-Free Microbore Extension Set,
list 123130402, lots 86002HG, 86044HG, 87012HG,
87119HG, 90016HG, 90081NS, 92144NS;
k) LifeShield Latex-Free Microbore Extension Set INT,
6 Inch, list 123320401, lot 931375H;
l) LifeShield Latex-Free Tri-Leg Microbore Extension
Set, list 123340401, lots 880605H, 891895H, 930945H,
950675H;
m) LifeShield Latex-Free Tri-Leg Extension Set,
list 123460401, lots 88122HG, 89115HG, 920815H;
n) LifeShield Latex-Free Microbore Extension Set,
list 124390401, lot 88176HG;
o) LifeShield Latex-Free Extension Set, 6 Inch,
list 191420448, lots 87188HG, 89021HG, 93025R5;
p) Sterile Latex-Free Microbore Extension Set,
list 191700204, lot 89135HG;
q) Sterile Latex-Free Microbore Extension Set,
list 191700404, lots 010115H, 892045H, 911495H,
930965H, 940855H;
r) Microbore Extension Set, list 191700415, lot 961935H;
s) LifeShield Latex-Free Macrobore Extension Set, 46
Inch, list 192220448, lots 921425H, 960425H;
t) LifeShield Latex-Free Y-Type Connecting Set, 9 Inch,
list 193130448, lots 88138HG, 881405H, 941705H
u) LifeShield Latex-Free Macrobore Extension Set,
list 193280448, lots 900545H, 910305H;
v) LifeShield Latex-Free Microbore Extension Set, 19
Inch, list 193320448, lot 02043R5;
Please Note: items p, q & r (list 191700204, 191700404
and 191700415) were packaged in kits with Sporanox
Injection distributed by Ortho Biotech Products,
Raritan, NJ.
C) a) Latex-Free Primary I.V. Set, Nonvented, 100 Inch,
list 017280458, lots 920844W, 960784W;
b) Latex-Free Primary I.V. Set, Nonvented, 78 Inch,
list 018180448, lots 910604W, 960604W;
c) Latex-Free Primary I.V. Set, Nonvented, 100 Inch,
list 018190448, lot 020844W;
d) Latex-Free Primary I.V. Set, Convertible Pin, 70
Inch, list 018200478, lots 880884W, 891554W, 910614W,
920824W, 931134W, 960614W;
e) Primary I.V. Set, Nonvented, 72 Inch, list 018570448,
lots 010524W, 900634W, 940624W;
f) Latex-Free Primary I.V. Set, Nonvented, 78 Inch,
list 018590448, lots 891184W, 900844W, 920784W,
930444W, 930884W, 931214W, 941274W, 950684W, 960504W;
g) Primary I.V. Set, Nonvented, 78 Inch, list 018600448,
lot 920654W;
h) Latex-Free Primary I.V. Set, Nonvented, 80 Inch,
list 018770468, lots 901224W, 941124W, 950484W;
i) Latex-Free Y-Type Primary I.V. Set, Nonvented, 86
Inch, list 018790458, lot 960725H;
j) Latex-Free Primary I.V. Set, Vented, 78 Inch,
list 018810448, lots 860504W, 880454W, 890624W,
920904W **** expanded to include lots 010304W,
930454W, 930464W and 960514W ****;
k) Latex-Free Primary I.V. Set, Convertible Pin, 78
Inch, list 018810458, lots 890914W, 910824W, 911004W,
921134W, 930704W, 931234W, 931244W, 940544W, 950434W,
950694W, 951104W, 960524W, 960534W;
l) Latex-Free Primary I.V. Set, 78 Inch, list 030840448,
lot 960544W;
m) Latex-Free Primary I.V. Set, Convertible Pin, 80
Inch, list 049670478, lots 020884W, 901274W, 921004W,
940834W;
n) Latex-Free Primary I.V. Set, Convertible Pin, 80
Inch, list 049680478, lots 910894W, 921204W;
o) Latex-Free Primary I.V. Set, Convertible Pin, 80
Inch, list 049850478, lots 020524W, 910844W, 931254W,
950624W;
p) Latex-Free Cardiac Catheterization Set, Nonvented, 67
Inch, list 064140458, lot 931505H;
q) Latex-Free Manifold III with Secure Lock,
list 064620401, lot 89114HG;
r) Latex-Free Primary I.V. Set, Nonvented, 106 Inch,
list 080820448, lots 900874W, 901244W, 920974W,
930544W, 950634W, 950934W, 961044W;
s) Latex-Free Primary I.V. Set, Convertible Pin, 106
Inch, list 080830478, lots 880834W; 931294W;
t) Primary I.V. Set, Vented, 72 Inch, list 089620448,
lots 870514W, 880504W, 890934W, 891654W, 900524W,
901184W, 920554W **** expanded to include lots
020494, 930484W, 930904W, 931304W, 941094W, 950704W,
960964W and 960974W ****;
u) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 113060458, lots 920984W, 931094W; v) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 106 Inch, list 113080458, lots 920075H, 930455H,
940075H;
w) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 106 Inch, list 113090458, lots 871174W, 881054W,
901254W, 910854W, 920994W, 930554W, 930964W, 940584W,
940944W, 941304W, 950514W, 950524W, 950744W, 960584W; x) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 114110478, lots 910654W, 950584W; y) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 70 Inch, list 115390478, lots 880985H, 911035H,
931305H;
z) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch, list 115400458, lots 870974W, 900934W,
911284W, 921184W, 940634W, 950664W, 960764W, 961104W,
961114W;
aa) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 78 Inch, list 115410458, lot 920115H;
bb) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch, list 115420458, lot 921194W;
cc) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 78 Inch, list 115450458, lots 900964W, 910914W,
921224W, 931144W, 951124W;
dd) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch, list 115500478, lots 891354W, 951064W;
ee) Latex-Free Primary I.V. Set, Convertible Pin, 80
Inch, list 115530458, lots 021235H, 911285H,
940325H;
ff) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 116780478, lot 87123HG;
gg) LifeShield Latex-Free Primary I.V. Set, Nonvented,
100 Inch, list 116790448, lot 930075H;
hh) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch, list 117190478, lot 881334W;
ii) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch, list 117350478, lot 881395H;
jj) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 80 Inch, list 117360478, lot 900385H;
kk) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 70 Inch, list 117390478, lots 900355H, 940395H; ll) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 117620478, lot 901435H
mm) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 119600468, lots 010544W,
020704W, 871204W, 900974W, 901104W, 901304W,
910664W, 910924W, 920684W, 920874W, 930594W,
930804W, 931154W, 940844W, 941004W, 941174W,
950594W, 950604W, 950824W, 960644W, 960874W;
nn) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 119610468, lots 010554W,
010564W, 010574W, 010584W, 010594W, 020714W,
870754W, 870764W, 870774W, 871034W, 880724W,
880744W, 880964W, 880994W, 890814W, 890824W,
901114W, 910674W, 910684W, 911334W, 920694W,
921014W, 921024W, 921264W, 921274W, 921284W,
921294W, 921304W, 930604W, 930614W, 930624W,
930634W, 930814W, 931004W, 931014W, 931164W,
940654W, 940664W, 940674W, 940854W, 940864W,
941014W, 941024W, 941034W, 941184W, 941194W,
941354W, 941364W, 950834W, 950844W, 950974W,
950984W, 951074W, 951084W, 951094W, 960884W,
961154W, 961164W, 961174W, 961184W;
oo) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 119620478, lots 891334W,
900584W, 901214W, 910574W, 911034W, 911254W,
920794W, 951114W;
pp) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 119630468, lots 020965H,
910035H, 910135H, 920015H, 930095H, 940085H,
960155H;
qq) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 119650468, lots 010404W,
010414W, 010424W, 020554W, 020564W, 020984W,
020994W, 021194W, 021204W, 870924W, 870934W,
870944W, 880474W, 911264W, 920474W, 920814W,
921074W, 930744W, 930754W, 930974W, 930984W,
931104W, 931414W, 931424W, 931434W, 940814W,
940824W, 940954W, 941154W, 941314W, 950534W,
950544W, 950754W, 960594W960744W, 960754W, 960834W,
961054W, 961064W, 961074W;
rr) LifeShield Latex-Free Primary I.V. Set, Nonvented,
105 Inch, list 119970448, lot 950155H;
ss) Latex-Free Primary I.V. Set, Convertible Pin, 112
Inch, list 120580478, lot 911235H;
tt) LifeShield Latex-Free Primary I.V. Set, Nonvented,
110 Inch, list 120590448, lots 020545H, 890185H;
uu) Latex-Free Fat Emulsion I.V. Set, Convertible Pin,
110 Inch, list 120600458, lot 911515H;
vv) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 124260448, lot 921435H;
ww) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 124520448, lot 880685H;
xx) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 124530448, lots 020045H,
920295H;
yy) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 110 Inch, list 125720448, lot 88161HG;
zz) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 100 Inch, list 125740448, lot 921045H;
aaa) Primary I.V. Set, Nonvented, 72 Inch, list
150620448, lot 911565H;
bbb) Latex-Free Primary I.V. Set, Convertible Pin, 84
Inch, list 151280478, lot 89116HG;
ccc) Primary I.V. Set, Nonvented, 93 Inch,
list 153550448, lot 960315H;
ddd) Latex-Free Primary I.V. Set, Convertible Pin, 78
Inch, list 153990458, lot 892035H;
eee) Latex-Free Primary I.V. Set, Nonvented, 78 Inch,
list 154090448, lot 931085H;
fff) Latex-Free Primary I.V. Set, Convertible Pin,
83 Inch, list 170400478, lot 940695H;
ggg) LifeShield Latex-Free Y-Type Anesthesia I.V. Set,
Nonvented, 130 Inch, list 190580448, lot 87021HG; hhh) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 135 Inch, list 190920401, lots 86025HG,
89013HG;
iii) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Piercing Pin, 112 Inch, list 191090448,
lots 85047HG, 88078HG, 89108HG, 911625H;
jjj) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 112 Inch, list 191100448,
lots 85048HG, 87014HG, 87151HG, 88059HG, 89053HG,
89122HG, 911635H, 931215H;
kkk) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 111 Inch, list 191110448,
lots 85156HG, 87152HG, 89065HG, 910785H, 930485H; lll) LifeShield Latex-Free Primary I.V. Set, Nonvented,
105 Inch, list 191180448, lot 96019R5;
mmm) LifeShield Latex-Free Prim. I.V. Set, Convertible
Pin, 110 Inch, list 191330448, lots 03016R5,
93046R5, 94023R5, 95024R5;
nnn) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 124 Inch, list 191370458, lots 86039HG,
87154HG, 89039HG, 941165H, 961255H;
ooo) LifeShield Latex-Free Primary I.V. Set with
Convertible Pin, list 191520448, lot 88134HG;
ppp) LifeShield Latex-Free Primary Piggyback I.V. Set,
Convertible Pin, list 192070448, lot 01021R5;
qqq) LifeShield Latex-Free Primary I.V. Set, Convertible
Piercing Pin, 147 Inch, list 192170448,
lots 011425H, 87036HG, 88110HG;
rrr) Latex-Free Primary I.V. Set, Convertible Pin, 82
Inch, list 192180448, lots 86142HG, 88095HG,
88170HG, 89111HG, 911085H, 941215H;
sss) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 83 Inch, list 192290448, lots 87134HG,
88096HG, 930445H;
ttt) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 101 Inch, list 192410478, lots 88125HG,
88147HG, 891435H, 951525H;
uuu) LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 107 Inch, list 192530448, lot 86139HG;
vvv) LifeShield Latex-Free Primary I.V. Set, Nonvented,
124 Inch, list 192600401, lot 911005H;
zzz) LifeShield Latex-Free Primary I.V. Set, Nonvented,
110 Inch, list 192620448, lot 960815H;
aaaa) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 141 Inch, list 192670448,
lot 96020R5;
bbbb) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 126 Inch, list 192680448,
lot 94019R5;
cccc) Continuum LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 112 Inch, list 192770448, lots
020355H, 87020HG, 88111HG, 910815H, 930495H,
941055H, 950335H;
dddd) LifeShield Latex-Free Primary I.V. Set, Nonvented,
127 Inch, list 192990448, lot 02057R5;
eeee) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 112 Inch, list 193110448, lots
87155HG, 960455H;
ffff) Latex-Free Primary I.V. Set, Convertible Pin,
83 Inch, list 193210448, lots 871365H, 921025H;
gggg) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 111 Inch, list 193240448,
lots 88079HG, 940255H
hhhh) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 104 Inch, list 193260448,
lot 931355H;
iiii) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 138 Inch, list 193270448,
lots 88014HG, 88051HG, 930505H, 941585H;
jjjj) LifeShield Latex-Free Primary I.V. Set, Nonvented,
102 Inch, list 193310448, lot 01025R5;
kkkk) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 136 Inch, list 193440448,
lots 02023R5, 88026R5, 89026R5, 92033R5;
llll) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 136 Inch, list 193490448,
lot 95026R5;
mmmm) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 109 Inch, list 193570448,
lots 02022R5, 86146HG, 93027R5;
nnnn) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 125 Inch, list 193590448,
lot 88164HG;
oooo) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 80 Inch, list 195040448,
lot 01032R5;
pppp) Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch with 2 Injection Sites, Microdrip,
list 017230478, lots 891965H, 950585H;
qqqq) LifeShield Latex-Free Prim. I.V. Set, Convertible
Pin, 110 Inch, list 193480448,lots 87038HG,
901605H;
Please note, item k, list 018810458, lot 910824W, was also case packed with Liposyn II 20%, list 09793-04-03, lot 94533DF and list 09792-04-02, lot 92522DF;
D) a) LifeShield Latex-Free Primary I.V. Pump Set with
Distal Microbore Patient Line, Convertible Pin, 110
Inch, list 011690402, lots 90113NS, 92071NS, 94087NS,
94139NS, 96080NS;
b) Latex-Free Enteral PlumSet, Vented, 98 Inch, list
014790402, lots 86119HG, 88086HG;
c) Latex-Free Enteral PlumSet, Vented, 98 Inch, list
014794202, lot 87127HG;
d) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 016420448, lots
010365H, 011205H, 900955H, 910495H, 911415H, 920165H,
920665H, 930325H, 930865H, 931125H, 940725H, 940735H,
941405H, 941735H, 950165H, 950885H, 951205H, 961355H,
961625H;
e) LifeShield Latex-Free Secondary I.V. PlumSet,
Convertible Pin, 32 Inch, list 016430448, lot
941635H;
f) LifeShield Latex-Free High-Pressure Filter Primary
I.V. PlumSet, Convertible Pin, 112 Inch, list
016440448, lot 911275H;
g) LifeShield Latex-Free High-Pressure Filter Primary
I.V. PlumSet, Convertible Pin, 112 Inch, list
016450448, lot 950085H;
h) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 016460448, lots
911105H, 941455H;
Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 016480448, lots 900965H, 901025H,
930875H;
Latex-Free Primary I.V. PlumSet -OL, Convertible Pin,
list 016486148, lots 890695H, 890755H, 890765H,
910205H, 910505H, 911425H, 911435H, 921595H, 921605H,
930615H, 940435H;
Lifeshield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 016500448, lots
881515H, 900415H, 901615H, 911095H, 931135H, 941745H,
951215H, 961615H;
Latex-Free, Primary I.V. Plumset - OL, Convertible
Pin, 104 Inch, list 016516148, lots 891265H, 891275H,
891285H, 901575H, 901585H, 930345H, 930725H, 930735H,
941225H;
LifeShield Latex-Free Microdrip Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 017350478, lot 911045H; n) Latex-Free Soluset 150 mL Burette I.V. Pump Set, Vented, 114 Inch, list 017530402, lots 87121HG, 87173HG, 88064HG, 88101HG, 89048HG, 911555H;
Latex-Free Nitroglycerin Primary I.V. Pump Set,
Convertible Pin, 107 Inch, list 017720478, lot
900265H;
p) LifeShield Latex-Free Microdrip Nitroglycerin
PlumSet, Convertible Pin, 107 Inch, list 024270478,
lot 930625H;
q) LifeShield Latex-Free Microdrip Nitroglycerine
PlumSet, Convertible Pin, list 024276178, lot
950185H;
r) Latex-Free Primary I.V. Pump Set, Convertible Pin,
105 Inch, list 037040478, lots 021255H, 890395H,
900475H, 901375H, 901385H, 910265H, 920245H, 940305H;
s) Latex-Free Primary I.V. PlumSet, Convertible Pin, 107
Inch, list 064400412, lots 890165H, 920465H, 941415H
t) LifeShield Latex-Free Microdrip Soluset 50 mL Burette
PlumSet, Convertible Pin, 105 Inch, list 064460403,
lot 87136HG;
u) Latex-Free Enteral PlumSet with Integral Container,
Nonvented, 105 Inch, list 064920402, lots 031024W,
88046HG;
v) Latex-Free Microdrip Primary I.V. Micro Pump Set,
Vented, 102 Inch, list 092430448, lots 891975H,
920065H;
w) Latex-Free Soluset Microdrip 150 mL Burette Micro Pump
Set, Vented, 124 Inch, list 092470468, lots 88063HG,
88152HG, 89061HG;
x) Latex-Free Specialty I.V. Pump Set-HB, Convertible
Pin, 105 Inch, list 111550478, lot 88149HG;
y) LifeShield Latex-Free HEMA Blood PlumSet, Nonvented,
110 Inch, list 112350403, lots 87037HG, 88104HG,
89101HG, 920855H, 940175H;
z) LifeShield Latex-Free Hemoset 100 mL Burette I.V.
PlumSet, Nonvented, 105 Inch, list 112410403, lots
85031HG, 87169HG, 90013HG, 921515H;
aa) Latex-Free Primary I.V. PlumSet, Nonvented, 112 Inch,
list 113400402, lots 86082HG, 910625H, 930825H,
950555H, 961085H;
bb) LifeShield Latex-Free Secondary I.V. PlumSet,
Convertible Pin, 18 Inch, list 114170478, lots
900665H, 930555H;
cc) LifeShield Latex-Free Primary I.V. PlumSet,
Nonvented, 104 Inch, list 114190412, lots 011215H,
951095H;
dd) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 115940412, lots
87074HG, 920405H;
ee) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 115950412, lots
85164HG, 941665H;
ff) Latex-Free Primary I.V. Pump Set, Convertible Pin,
110 Inch, list 116060401, lots 850515H, 881345H;
gg) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 116620412, lots
930785H, 950565H;
hh) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 122 Inch, list 116640403, lots 85052HG,
910705H, 920555H, 941005H, 950305H, 951015H;
ii) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 116870401, lot
010915H;
jj) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 105 Inch, list 116970448, lots
891235H, 940595H;
kk) Latex-Free Soluset 150 mL Burette PlumSet,
Convertible Pin, 114 Inch, list 117060402, lots
87144HG, 88105HG, 89049HG, 930135H;
ll) LifeShield Latex-Free Microdrip Soluset 150 mL
Burette PlumSet, Convertible Pin, 124 Inch, list
117140402, lot 89097HG;
mm) LifeShield Latex-Free HEMOSET, 100 mL Burette I.V.
PlumSet, Nonvented, 141 Inch, list 118500402, lot
942025H;
nn) Latex-Free Secondary I.V. PlumSet, Convertible Pin,
18 Inch, list 118770448, lots 900295H, 920485H,
940415H, 960145H;
oo) Latex-Free Nitroglycerin PlumSet, Convertible Pin,
107 Inch, list 118780412, lots 901445H, 910635H,
920415H, 930565H, 941685H, 951135H;
pp) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 118840458, lots
01016R5, 88088HG, 92047R5, 93053R5;
qq) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 119430412, lots
010385H, 010985H, 020155H, 020165H, 020175H, 020605H,
891475H, 891595H, 891605H, 891625H, 891635H, 900425H,
900435H, 900445H, 900455H, 900985H, 920175H, 920185H,
930245H, 930365H, 930375H, 930385H, 930635H, 930645H,
930655H, 930665H, 930885H, 931145H, 931155H, 931165H,
940445H, 940455H, 940465H, 940475H, 940485H, 940745H,
940755H, 940765H, 940775H, 941265H, 941275H, 941285H,
941465H, 941475H, 941755H, 941765H, 941775H, 950245H,
950255H, 950265H, 950625H, 951235H;
rr) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 139 Inch, list 119440402, lots 84133HG, 84156HG,
88076HG;
ss) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 112 Inch, list 119460412, lots
84180HG, 930285H, 940335H, 940605H;
tt) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 119470412, lot
941185H; uu) LifeShield Latex-Free Microdrip Soluset
150 mL Burette PlumSet, Convertible Pin, 124 Inch,
list 119480402, lots 84022HG, 85023HG, 87034HG,
87146HG, 87182HG, 87183HG, 88065HG, 88107HG, 940195H,
940895H, 950315H, 951345H;
vv) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 139 Inch, list 119490402, lot 88108HG;
ww) Latex-Free Microdrip Soluset 150 mL Burette Pump Set,
Convertible Piercing Pin, 124 Inch, list 119760402,
lots 88109HG, 89063HG, 90002HG, 911775H;
xx) LifeShield Latex-Free Microdrip Soluset 150 mL
Burette PlumSet, Convertible Pin, 124 Inch, list
119770403, lots 88131HG, 89124HG, 920865H, 961055H;
yy) LifeShield Latex-Free Soluset 150 mL Burette I.V.
PlumSet, Convertible Pin, 114 Inch, list 119790402,
lot 87147HG;
zz) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 139 Inch, list 119800403, lots 89051HG, 960905H;
aaa) Latex-Free Nitroglycerin Primary I.V. Pump Set,
Convertible Pin, 110 Inch, list 119930478, lots
910145H, 920125H;
bbb) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 120300412, lots
021365H, 860795H, 860815H, 860955H, 871125H,
881455H, 881505H, 881525H, 890795H, 891295H,
891645H, 892075H, 901005H, 901335H, 901345H,
901355H, 911125H, 920205H, 920215H, 930895H,
940505H, 940515H, 941485H, 941785H;
ccc) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 121190412, lot
960645H;
ddd) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch, list 121610401,
lots 86121HG, 87105NS, 89111NS, 89158NS, 90072NS;
eee) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch, list 121620401, lots
01061NS, 89112NS;
fff) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch, list 121630401, lots
88173HG, 89139NS;
ggg) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 122 Inch, list 122590402, lots 010775H,
030885H, 85045HG, 87031HG, 87148HG, 88057HG,
880805H, 890465H, 891745H, 901505H, 930165H,
940205H, 951355H, 960385H;
hhh) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 122600412, lots
010055H, 900375H, 900395H, 920155H, 921765H,
930055H, 940065H, 940425H, 961125H;
iii) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 123390412, lot
931075H;
jjj) LifeShield Latex-Free Primary I.V. Pump Set,
Convertible Pin, 110 Inch, list 123830401, lots
87004HG, 87174HG, 88132HG, 891325H, 911325H,
960395H;
kkk) LifeShield Latex-Free Fat Emulsion I.V. PlumSet,
Convertible Pin, 104 Inch, list 125380448,
lot 951435H;
lll) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 112 Inch, list 125630412,
lot 951455H;
mmm) LifeShield Latex-Free 150 mL Burette PlumSet,
Convertible Pin, 114 Inch, list 125640402,
lot 951485H;
nnn) LifeShield Latex-Free GemStar Primary Piggyback Pump
Set-SL, Convertible Pin, 110 Inch, list 132670401,
lot 942315H;
ooo) Latex-Free GemStar Primary Piggyback I.V. Pump Set-
SL, list 132686101, lots 86106HG, 88042HG;
ppp) Latex-Free Enteral PlumSet, Nonvented, 98 Inch,
list 190140402, lots 87132HG, 942095H, 93049R5,
93050R5, 95022R5;
qqq) Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 190430412, lot 88089HG;
rrr) LifeShield Latex-Free Primary I.V. PlumSet,
Nonvented, 113 Inch, list 190500412, lots 911255H,
950045H;
sss) LifeShield Latex-Free Nitroglycerin Primary I.V.
PlumSet, Convertible Pin, 107 Inch, list 190860412,
lot 93033R5;
ttt) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 118 Inch, list 191210402, lots 87153HG,
88056HG;
uuu) LifeShield Latex-Free Primary I.V. Plumset,
Convertible Pin, 104 Inch, list 192100412, lots
89110HG, 93044R5, 96039R5;
vvv) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 124 Inch, list 192310412, lot 85181HG
www) LifeShield Latex-Free 50 mL Burette PlumSet,
Convertible Pin, 107 Inch, list 192540402, lot
89128HG;
aaaa) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 135 Inch, list 192650448, lots
86036R5, 89029R5, 92044R5, 96018R5;
bbbb) LifeShield Latex-Free Microdrip Soluset 100 mL
Burette PlumSet, Convertible Pin, 121 1/2 Inch,
list 192890402, lots 85034HG, 85059HG, 88083HG,
960445H;
cccc) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 103 Inch, list 193060412, lots
01019R5, 92042R5, 92043R5, 941395H;
dddd) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 110 Inch, list 193380412, lots
01026R5, 87170HG, 92046R5;
eeee) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 108 Inch, list 193400412, lots
02058R5, 94040R5;
ffff) LifeShield Latex-Free Microdrip Soluset with High-
Pressure Filter 150 mL Burette PlumSet, Convertible
Pin, 137 Inch, list 193470402, lot 960945H;
gggg) LifeShield Latex-Free Soluset 100 mL Burette
PlumSet, Convertible Pin, 121 Inch, list 193510402,
lots 84043HG, 911825H, 950355H;
hhhh) LifeShield Latex-Free Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 193600412, lots
88163HG, 88169HG, 921785H;
E) a) Latex-Free Secondary I.V. Set, Convertible Pin, 32
Inch, list 018320468, lots 010015H, 911055H, 921285H,
940565H, 950785H;
b) Latex-Free Secondary I.V. Set, Nonvented, 32 Inch,
list 018610458, lots 901305H, 910215H, 921465H,
960735H;
c) Latex-Free Secondary I.V. Set, Convertible Pin, 35
Inch, list 018890458, lots 920695H, 950175H;
d) Latex-Free Secondary I.V. Set with Convertible Pin,
32 Inch, list 019110448, lots 85163HG, 960535H;
e) Latex-Free Secondary I.V. Set, Nonvented, 35 Inch,
list 019260448, lot 941645H;
f) Latex-Free Midlength Secondary I.V. Set, 40 Inch,
list 111810401, lots 86029HG, 89100HG;
g) LifeShield Latex-Free Secondary I.V. Set, Nonvented,
32 Inch, list 113110448, lots 010324W, 010724W,
910534W, 920934W, 930494W, 950444W, 950714W;
h) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch, list 113970458, lots 910624W, 910634W,
911304W, 920674W, 920854W, 920864W, 921214W, 930784W,
931314W, 931324W, 940994W, 941334W, 950574W, 950814W,
950964W, 951054W, 960794W, 960864W;
i) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch, list 114850458, lot 911234W;
j) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch, list 119530448, lots 010464W, 010474W,
010484W, 010494W, 010504W, 010794W, 010804W, 020634W,
020654W, 020664W, 021034W, 870534W, 870554W, 870874W,
870884W, 871114W, 880674W, 890674W, 900864W, 901044W,
910554W, 910834W, 911244W, 920564W, 920574W, 920944W,
920954W, 921174W, 930504W, 930514W, 930524W, 930714W,
930724W, 930924W, 930934W, 931064W, 931074W, 940554W,
940564W, 940774W, 940784W, 940914W, 940924W, 941104W,
941114W, 941284W, 941294W, 9500464W, 950474W,
950724W, 950924W, 960564W, 960984W, 960994W, 961004W;
k) LifeShield Latex-Free Secondary I.V. Set, Convertible
Pin, 32 Inch, list 119540448, lots 860994W, 861244W;
l) ColorGard Latex-Free Midlength Secondary I.V. Set,
Convertible Pin, 40 Inch, list 405210448, lot
911265H;
m) ColorGard Latex-Free Midlength Secondary I.V. Set,
Convertible Pin, 40 Inch, list 405220448, lots
890215H, 950135H;
ColorGard Latex-Free Midlength Secondary I.V. Set,
Convertible Pin, 40 Inch, list 405240448, lots
910075H, 910155H;
Latex-Free Midlength Secondary I.V. Set, Convertible
Pin, 40 Inch, list 011390448, lots 010814W, 880514W,
900944W, 901094W, 901264W, 910884W, 920834W, 921084W,
930574W, 930764W, 940644W, 940974W, 950564W, 950804W,
960634W, 960854W, 961134W.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letters dated June 9, 2003, June 13, 2003, and July 7, 2003. Firm initiated recall is ongoing.
REASON
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
VOLUME OF PRODUCT IN COMMERCE
70,062,517 sets, 1,079,350 chambers.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. Catalog # 027819201. Recall # Z-0960-03.
CODE
Lot Number 0304300106.
RECALLING FIRM/MANUFACTURER
Cobe Cardiovascular, Inc, Arvada, CO, by telephone and letter on May 9, 2003. Firm initiated recall is complete.
REASON
Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
VOLUME OF PRODUCT IN COMMERCE
60 units.
DISTRIBUTION
MN, NE, and OK.

_______________________________
PRODUCT
a) Medamicus FlowGuard 16FR Valved Peelable Introducer
Kit, Catalog Number 10532-011. Recall # Z-0962-03;
b) Medamicus FlowGuard 15FR Valved Peelable Introducer
Kit, Catalog Number 10532-010. Recall # Z-0963-03;
c) Angio Dynamics 14F EmboSafe Valved Peelable Introducer,
5 units per shelf box, Catalog number 06507601.
Recall # Z-0964-03;
d) Angio Dynamics 15F EmboSafe Valved Peelable Introducer,
5 units per shelf box, Catalog number 06507602.
Recall # Z-0965-03;
e) Angio Dynamics 16F EmboSafe Valved Peelable Introducer,
5 units per shelf box, Catalog number 06507603.
Recall # Z-0966-03;
f) Medamicus FlowGuard 16FR Valved Peelable Introducer
Kit, Catalog Number 10684-003. Recall # Z-0967-03
g) Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number
10614-011. Recall # Z-0968-03.
CODE
a) Lot Number W23152;
b) Lot Number W23155;
c) Lot Numbers W24305, W24310, and W24311;
d) Lot Numbers W24306 and W24313;
e) Lot Numbers W24307, W24316, and W24317;
f) Lot Number W24369;
g) Lot Number W24540.
RECALLING FIRM/MANUFACTURER
MedAmicus, Inc., Plymouth, MN, by letters dated June 6, 2003 or June 20, 2003. Firm initiated recall is ongoing.
REASON
Stability testing, after accelerated aging of the device, shows that the handle of device does not meet strength specifications.
VOLUME OF PRODUCT IN COMMERCE
8,467 units.
DISTRIBUTION
GA, MO, NY, and NC.

_______________________________
PRODUCT
Misys Laboratory System. Recall # Z-0972-03.
CODE
Version 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by Recall Notice on March 19, 2003. Firm initiated recall is complete.
REASON
Abnormal results are flagged as normal.
VOLUME OF PRODUCT IN COMMERCE
1.
DISTRIBUTION
NE.

_______________________________
PRODUCT
Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit. Catalog # FR-8050. Recall # Z-0973-03.
CODE
Lot #204016, Exp 09 NOV 02.
RECALLING FIRM/MANUFACTURER
PerkinElmer Life Sciences, Inc., Norton, OH, by telephone on May 16, 2002. Firm initiated recall is complete.
REASON
The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
VOLUME OF PRODUCT IN COMMERCE
10 kits.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Misys Laboratory System using Microbiology versions 5.2 (build 4 and higher), 5.23 and 5.3. Recall # Z-0974-03.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax dated June 2, 2003. Firm initiated recall is ongoing.
REASON
Susceptibility comments are ommited from Microbiology cumulative reports.
VOLUME OF PRODUCT IN COMMERCE
471.
DISTRIBUTION
Nationwide and Internationally,

_______________________________
PRODUCT
Acuson Cypress Echocardiography System, Imaging System. Catalog # 8264604. Recall # Z-0975-03.
CODE
Serial numbers 70000 through 72000.
RECALLING FIRM/MANUFACTURER
Siemans Medical Solutions USA, Inc., Plymouth Meeting, PA, by letter dated April, 2003. Firm initiated recall is ongoing.
REASON
Software problem - loss of data.
VOLUME OF PRODUCT IN COMMERCE
1,540 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Axiom Sensis. Programmable Diagnostic Computer. Recall # Z-0979-03.
CODE
Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Malvern, PA, by letter in May 2003. Firm initiated recall is ongoing.
REASON
Software problem - erroneous results or system crashes.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MA, and MI.

_______________________________
PRODUCT
Deltec CASS-Prizm PCS II Ambulatory Infusion Pump with Revision E Software. Recall # Z-0980-03.
CODE
Pump Serial numbers 658825, 658837, 658840, 658842,
658844 - 658865, 658867, 658869 - 658896, 658898 - 658918, 658920 - 658936, 658941, 658943 - 658947, 658949,
662473 - 662477, 662483, 662485, 662488 - 662490, and 662635 - 662659.
RECALLING FIRM/MANUFACTURER
Deltec, Inc., St. Paul, MN, by letter on June 23, 2003. Firm initiated recall is ongoing.
REASON
Pump keyboard entries by the patient can result in the patient having unintended access to programming screens and result in improper drug dosage.
VOLUME OF PRODUCT IN COMMERCE
135 pumps.
DISTRIBUTION
NC, and WA.

_______________________________
PRODUCT
A.R.C. Laser Photolysis Probes/Handpieces. Catalog Number LY11002. Recall # Z-0981-03.
CODE
Part Number: 1A55LM02.
RECALLING FIRM/MANUFACTURER
A. R. C. Laser Corp., Salt Lake City, UT, by telephone on June 6, 2003, and by fax and letter on June 10, 2003. Firm initiated recall is ongoing.
REASON
Product may not have been properly sterilized.
VOLUME OF PRODUCT IN COMMERCE
370 units.
DISTRIBUTION
IN, NY, PA, and TX.

_______________________________
PRODUCT
CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a "zig" pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths. Recall # Z-0983-03.
CODE
All lots produced.
RECALLING FIRM/MANUFACTURER
Numed Inc., Hopkinton, NY, by letters dated June 26, 2003. FDA initiated recall is ongoing.
REASON
Lacks a 510k clearance for marketing.
VOLUME OF PRODUCT IN COMMERCE
169 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Axiom Aristos X-Ray System. Recall # Z-0984-03.
CODE
Part numbers 5895003 and 7414803. Serial numbers 01001, 01170, 01219, 01221, and 01030.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated April 19, 2003. Firm initiated recall is ongoing.
REASON
Software malfunction. May indicate that the image is flipped when it is not.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
FL, MO, OK, and CO.

_______________________________
PRODUCT
3D Ceiling Suspension. Recall # Z-0987-03.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated April 15, and April 23, 2003. Firm initiated recall is ongoing.
REASON
The back up safety catch may not function properly.
VOLUME OF PRODUCT IN COMMERCE
3,504 units.
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
CryoValve Allograft Aortic Valve and Conduit. Recall # Z-0988-03.
CODE
Donor #66810, Device Serial #8100262, Model #AV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letters on May 5, 2003. Firm initiated recall is complete.
REASON
Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy..
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Clinitron CII Air Fluidized Therapy unit.
Recall # Z-0989-03;
b) Clinitron Up-Lift Air Fluidized Therapy unit.
Recall # Z-0990-03.
CODE
a) Model CII, Serial # CC (all numeric codes).
b) Model: Uplift, Serial # CH (all numeric codes).
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc., Charleston, SC, by letter on May 5, 2003. Firm initiated recall is ongoing.
REASON
Malfunction of side-rail latching pin coupled with inadequate directions for use.
VOLUME OF PRODUCT IN COMMERCE
122 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Nipro SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set. Recall # Z-0408-03.
CODE
All catalog numbers and all lot numbers distributed between 10/24/2001 and 11/01/2002.
RECALLING FIRM/MANUFACTURER
Nipro Corp, Miami, FL, by letter on November 8, 2002. Firm initiated recall is ongoing.
REASON
Air or fluid leakage at the hub/needle junction.
VOLUME OF PRODUCT IN COMMERCE
6,984,000.
DISTRIBUTION
Nationwide and Canada.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

______________________________
PRODUCT
Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055. Recall # Z-0961-03.
CODE
Lot No. 00008066; Expiration Date: 08-11-2001.
RECALLING FIRM/MANUFACTURER
Zeus Scientific, Inc., Branchburg, NJ, by letter on March 19, 2001. Firm initiated recall is complete.
REASON
Mix-up between low positive and negative controls.
VOLUME OF PRODUCT IN COMMERCE
15 kits.
DISTRIBUTION
NJ.

________________________________
PRODUCT
a) Neonatal Total Galactose Test Kit, Item #NG-1000,
Filter #903, contents for 960 assays.
Recall # Z-0969-03;
b) Neonatal Total Galactose Test Kit, Item #NG-4000, Filter
#903, contents for 4800 assays. Recall # Z-0970-03;
c) Neonatal Total Galactose Test Kit, Item #NG-1000E,
Filter #2992, contents for 960 assays.
Recall # Z-0971-03.
CODE
a) Lots: #112770, Exp 6/14/03, and #116017, Exp 7/4/03;
b) Lots: #112785, Exp 6/14/03, and #116002, Exp 7/4/03;
c) Lot: # 116020, Exp 7/4/03.
RECALLING FIRM/MANUFACTURER
PerkinElmer Life Sciences, Inc., Norton, OH, by telephone and facsimile on May 30, 2003. Firm initiated recall is ongoing.
REASON
The device is not stable throughout its labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
233 kits.
DISTRIBUTION
Nationwide and Internationally.

________________________________
PRODUCT
Magnetom Symphony/Sonata, OR Table. Recall # Z-0976-03.
CODE
Serial Numbers 021107 and 021941.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter in November, 2002. Firm initiated recall is complete.
REASON
OR Table stops during the transfer of the table to the MR system and will not move.
VOLUME OF PRODUCT IN COMMERCE
2.
DISTRIBUTION
CA, and TX.

________________________________
PRODUCT
Soft Contact Lenses (toric) packaged under the following labels: CV/ENCORE toric (methafilcon A) and ONEVUE 55 toric (methafilcon A) flexible wear. Recall # Z-0978-03.
CODE
There are 768 lot numbers as follows: 3669001157, 3669001465, 3669001756, 3669001960, 3669002711, 3669002714, 3669002816, 3669003208, 3669003214, 3669500011, 3669500414, 3669500514, 3779000756, 3779001722, 3779002117, 3779002513, 3779002911, 3779003020, 3779003624, 3779003906, 3779005316, 3779500013, 3779500120, 3890000722, 3890001706, 3891001712, 3892000954, 3892001402, 3892001414, 3892001712, 3893001417, 3893001611, 3893001711, 3893002612, 3893002613, 3893002712, 3893003020, 3893003107, 3893003302, 3893003614, 3893004706, 3893004806, 3893500111, 3893500702, 3893500802, 3893500902, 3894001058, 3894001560, 3894001654, 3894002213, 3894002607, 3894002610, 3894002811, 3894003005, 3894004306, 3894004502, 3894004904, 3894005004, 3894500205, 3894500310, 3894500311, 3894500313, 3894500402, 3894500411, 3894500511, 3894500704, 3894500706, 3895001456, 3895002758, 3895002855, 3895003024, 3895003220, 3895003315, 3895003320, 3895003514, 3895003614, 3895003660, 3895004312, 3895004512, 3895004807, 3895004907, 3895005210, 3895005403, 3895005904, 3895006004, 3895006305, 3895006405, 3895006406, 3895006505, 3895006808, 3895500112, 3895500114, 3895500212, 3895500214, 3895500360, 3895500607, 3895500608, 3895500656, 3895500708, 3895500805, 3895500806, 3895500808, 3895500906, 3895501006, 3895501104, 3895501106, 3895501206, 3895501306, 3896001066, 3896001256, 3896001458, 3896001751, 3896001912, 3896002309, 3896002903, 3896003300, 3896003400, 3896003500, 3896500112, 3896500200, 3896500403, 3897000656, 3897002209, 3897002224, 3897002506, 3897002808, 3897002814, 3897002820, 3897003904, 3897500008, 3897500106, 3898000756, 3901001610, 3903000757, 3903000857, 3903001051, 3903002411, 3903002602, 3903002814, 3903003707, 3903003713, 3903003807, 3903500007, 3903500107, 3903500214, 3903500311, 3904000402, 3904000561, 3904000657, 3904001251, 3904001356, 3904001717, 3904002060, 3904002313, 3904003018, 3904003102, 3904003202, 3904003204, 3904500002, 3904500103, 3904500203, 3904500213, 3904500305, 3905001157, 3905001257, 3905001665, 3905001852, 3905002026, 3905002056, 3905003321, 3905004115, 3905004260, 3905004455, 3905004505, 3905004615, 3905004705, 3905004911, 3905004914, 3905005011, 3905005014, 3905005111, 3905005114, 3905005124, 3905005602, 3905005702, 3905005724, 3905005802, 3905006316, 3905006416, 3905007506, 3905007812, 3905500017, 3905500105, 3905500117, 3905500210, 3905500410, 3905500411, 3905500414, 3905500515, 3905500607, 3905500616, 3905500708, 3905500716, 3905500720, 3905501004, 3906001552, 3906002614, 3906002714, 3907001260, 3907003006, 3907003511, 3907003607, 3907003614, 3907003714, 3907003716, 3907003816, 3907004112, 3907004308, 3907004424, 3907004524, 3907005410, 3907005710, 3907500011, 3907500210, 3907500324, 3911001411, 3912001262, 3912001265, 3912001905, 3912002224, 3912003400, 3912003611, 3912004007, 3912004107, 3912004207, 3912500011, 3912500107, 3913001255, 3913001460, 3913001462, 3913002205, 3913002814, 3913002910, 3913003010, 3913003110, 3913500105, 3913500205, 3913500308, 3914001462, 3914001923, 3914002155, 3914002165, 3914002255, 3914003160, 3914003311, 3914003322, 3914003411, 3914004513, 3914004524, 3914004613, 3914004624, 3914004907, 3914005007, 3914005116, 3914005205, 3914005305, 3914005405, 3914005505, 3914005605, 3914006614, 3914006702, 3914006703, 3914006902, 3914007408, 3914007508, 3914007508, 3914500011, 3914500105, 3914500111, 3914500205, 3914500308, 3914500313, 3914500413, 3914500903, 3915000862, 3915001060, 3915001265, 3915001453, 3915001455, 3915001654, 3915002605, 3915500065, 3915500205, 3916000851, 3916002513, 3916002602, 3916002702, 3916005504, 3916500204, 3921001051, 3921003118, 3921003218, 3921004000, 3921004024, 3921004124, 3921004212, 3921004224, 3921004312, 3921004414, 3921004606, 3921005220, 3921005311, 3921500212, 3921500224, 3921500312, 3921500314, 3921500324, 3921500412, 3921500512, 3922000926, 3922000960, 3922001907, 3922002017, 3922002052, 3922002224, 3922002508, 3922003416, 3922004016, 3922500306, 3922500316, 3922500424, 3923000857, 3923001960, 3923002155, 3923002360, 3923002551, 3923003152, 3923004517, 3923004617, 3923004717, 3923005005, 3923005105, 3923006602, 3923006613, 3923006813, 3923007307, 3923007322, 3923007407, 3923007422, 3923007914, 3923008014, 3923008108, 3923008114, 3923008208, 3923008308, 3923008406, 3923008412, 3923008506, 3923008610, 3923008612, 3923008920, 3923009010, 3923009210, 3923011016, 3923011216, 3923011316, 3923500151, 3923500152, 3923500311, 3923500317, 3923500407, 3923500417, 3923500505, 3923500507, 3923500513, 3923500517, 3923500622, 3923500705, 3923500722, 3923500805, 3923500906, 3923500910, 3923500914, 3923501006, 3923501010, 3923501014, 3923501106, 3923501110, 3923501210, 3923501312, 3923501416, 3923501516, 3924001051, 3924001154, 3924001455, 3924001558, 3924002304, 3924004100, 3924500208, 3925002100, 3925002107, 3925002513, 3925002624, 3925003120, 3925003416, 3925004011, 3925004510, 3925500116, 3927000865, 3930001205, 3930001305, 3930002409, 3930002712, 3931002206, 3931002812, 3932002118, 3932002801, 3932003205, 3932003305, 3932003708, 3932004116, 3932006700, 3932500016, 3932500105, 3932500201, 3932500212, 3932500400, 3932500500, 3933000564, 3933001405, 3933002220, 3933002706, 3933500005, 3933500300, 3933500400, 3934000805, 3934002706, 3934002904, 3934003012, 3939002914, 3939003106, 3939003812, 3939004120, 3940000957, 3940001152, 3940001909, 3940002305, 3940002410, 3940002914, 3940003908, 3940500108, 3940500114, 3941002258, 3941002452, 3941002651, 3941002665, 3941002955, 3941003518, 3941003719, 3941003722, 3941004824, 3941004920, 3941004924, 3941005009, 3941005020, 3941005109, 3941005220, 3941005710, 3941005712, 3941005804, 3941005812, 3941005904, 3941006004, 3941006010, 3941006106, 3941006108, 3941006610, 3941006700, 3941007000, 3941500216, 3941500322, 3941500410, 3941500508, 3941500510, 3941500511, 3941500520, 3941500524, 3941500608, 3941500620, 3941500708, 4308001960, 4308002711, 4308002816, 4308003214, 4308500114, 4308500214, 4309002513, 4309003624, 4314001611, 4314002612, 4314003020, 4314003202, 4314003614, 4314004706, 4314500006, 4314500220, 4315001560, 4315002213, 4315002611, 4315004306, 4315500102, 4315500210, 4315500310, 4316002855, 4316003024, 4316003124, 4316003220, 4316003314, 4316003320, 4316003414, 4316004312, 4316004412, 4316004807, 4316004907, 4316005904, 4316006306, 4316006408, 4316006506, 4316006608, 4316500014, 4316500108, 4316500204, 4316500306, 4317001912, 4317002309, 4317003200, 4317500160, 4318002109, 4318002209, 4318002224, 4318002820, 4318500014, 4323002411, 4324000402, 4324001560, 4324003102, 4324500260, 4325004255, 4325004260, 4325004911, 4325004914, 4325005107, 4325005114, 4325005124, 4325005702, 4325005802, 4325006216, 4325006316, 4325006810, 4325006910, 4325006920, 4325007108, 4325007208, 4325007812, 4325500107, 4325500111, 4325500124, 4325500255, 4325500360, 4326000960, 4326002508, 4326002614, 4326002714, 4327001260, 4327004424, 4327005410, 4332002224, 4332003611, 4332004107, 4333001360, 4333002814, 4333002910, 4333003010, 4333500160, 4334002155, 4334002165, 4334003160, 4334003311, 4334004524, 4334006614, 4334006902, 4334007408, 4334007508, 4334500124, 4334500224, 4335001060, 4335001265, 4335001355, 4336002513, 4336002602, 4341004024, 4341004212, 4341004414, 4341005220, 4342002508, 4342003416, 4342500106, 4343002160, 4343002511, 4343006602, 4343006813, 4343007007, 4343007107, 4343007914, 4343008014, 4343008306, 4343008406, 4343008512, 4343008612, 4343008710, 4343008920, 4343009010, 4343010916, 4343500007, 4343500160, 4343500320, 4344002109, 4344004100, 4344500265, 4344500304, 4344500355, 4344500365, 4344500455, 4344500465, 4345002513, 4345003120, 4350001060, 4350002409, 4350002712, 4351002206, 4351500060, 4351500106, 4351500112, 4351500160, 4351500212, 4352001060, 4352003708, 4352003808, 4352003912, 4352004012, 4352006500, 4352006600, 4352006700, 4352500008, 4352500160, 4353002220, 4353002706, 4353003000, 4353003200, 4353500160, 4354003012, 4360001155, 4360002814, 4360002914, 4360003808, 4360500108, 4360500109, 4360500110, 4361002665, 4361004724, 4361004824, 4361004920, 4361005024, 4361005109, 4361005216, 4361005712, 4361005804, 4361005911, 4361006008, 4361006010, 4361006210, 4361006510, 4361006700, 4361006800, 4361500009, 4361500016, 4361500120, 4361500300, 4361500365, 4361500455, 4361500555, 6591001465, 6591001960, 6598002213, 6598002611, 6599002855, 6599003315, 6599003414, 6599004312, 6599005904, 6608004355, 6608004911, 6608005602, 6608007108, 6609000960, 6616001460, 6616002205, 6616002910, 6617002155, 6617003411, 6617007408, 6617500005, 6617500005, 6618001355, 6626001960, 6626005005, 6626008920, 6626010916, 6627001455, 6627004100, 6627500065, 6634001805, 6634001905, 6635003205, 6635003708, 6635006600, 6636001255, 6636003000, 6636003200, 6636500006, 6636500006, 6643001155, 6643001265, 6643002814, 6644002665, 6644002955, 6644004724, 6644005020, 6644005712, 6644005712, 6644005804, 6644006110, 6644006700, 9198000601, 9198000613, 9198000712, 9198000812, 9199000713, 9201000313, 9215001213, 9215001712, 9215001812, 9215001912, 9215002012, 9801001851, 9804001706, 9807003614, 9809003320, 9811002224, 9814001610, 9818001157, 9818001864, 9820004524, 9825004007, 9838003516, 9843002409, 9844001905, 9853002305.
RECALLING FIRM/MANUFACTURER
Coopervision, Inc., Scottsville, NY, by letters dated June 24, 2003. Firm initiated recall is ongoing.
REASON
The actual sphere power of the lens is lower than the labeled value.
VOLUME OF PRODUCT IN COMMERCE
23,762 6-packs / 76,748 singles (trial lenses).
DISTRIBUTION
Nationwide, and Internationally.

________________________________
PRODUCT
V*CARE, Infant Resuscitator, with 40 cm H_O Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. Recall # Z-0982-03.
CODE
Lot numbers 3332838D, 333238D5; Product Codes: VN3100OCP, VN3100MC, VN3100OCP-B, VN3100MCP-2 and VN3100OCB.
RECALLING FIRM/MANUFACTURER
Ventlab Corporation, Mocksville, NC, by fax on March 15, 2003. Firm initiated recall is ongoing.
REASON
Printed bag with instructions to verify the pressure with a "certified manometer" was omitted in some of the product.
VOLUME OF PRODUCT IN COMMERCE
9 cases (10 units per case).
DISTRIBUTION
CA.

________________________________
PRODUCT
a) Proximate Linear Cutter with Safety Lock-Out,
Reloadable, contains 100 titanium staples with integral
knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.
Recall # Z-0985-03.
b) Proximate Linear Cutter with Safety Lock-Out,
Reloadable, contains 100 titanium staples with integral
knife, Product No. TLC10, staple size: 3 mm x 3.85 mm.
Recall # Z-0986-03.
CODE
a) Lot number: T4W32E, Exp 2008-03;
b) Lot number: T4W128, Exp 2008-03.
RECALLING FIRM/MANUFACTURER
Ethicon Endo-Surgery, Cincinnati, OH, by letter on May 21, 2003. Firm initiated recall is ongoing.
REASON
The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
VOLUME OF PRODUCT IN COMMERCE
240 instruments.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
ProLong Continuous Nerve Block Set. Recall # Z-1003-03.
CODE
All manufacturing codes were recalled. Model numbers: PL-50, PL-100.
RECALLING FIRM/MANUFACTURER
Life-Tech International, Inc, Stafford, TX, by letter on May 9, 2001. Firm initiated recall is complete.
REASON
Catheter does not fit through the needle resulting in delay of medical procedure.
VOLUME OF PRODUCT IN COMMERCE
207 boxes of 10 each.
DISTRIBUTION
CA, MN, TX, FL, and UT.

_______________________________
PRODUCT
a) Mitek Products. Profile 7 x 25 mm Cannulated
Interference Screw Round Head Catalog Number: 230325.
Recall # Z-1004-03;
b) Profile 8 x 20 mm Cannulated Interference Screw Round
Head Catalog Number: 230420. Recall # Z-1005-03.
CODE
a) Lot number 0207145 Exp 2007-7;
b) Lot number 0207146 Exp 2007-7.
RECALLING FIRM/MANUFACTURER
Mitek Worldwide, Norwood, MA, by letter on June 16, 2003
REASON
Mislabeled - Incorrect Screw Size. The unit labeled 7x25 mm screw may be a 8x20 mm; and the unit labeled 8x20 mm may be a 7x25 mm.
VOLUME OF PRODUCT IN COMMERCE
72.
DISTRIBUTION
CA, FL, NJ, MO, NY, OR, TX, VA, Argentina, Australia, Japan, Arab, Emirates, Portugal, and Spain.

________________________________
PRODUCT
Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number 6557. Recall # Z-1019-03.
CODE
Lot number 5404484.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letter on June 26, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm.
VOLUME OF PRODUCT IN COMMERCE
23 units.
DISTRIBUTION
CO, FL, IA, IL, NY, VT, TX, Singapore, and Korea.


END OF ENFORCEMENT REPORT FOR JULY 23, 2003

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