August 29, 2001 01-34RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-513-1 Deluxe Deviled Crabs, no code F-514-1 Deluxe Crab Rounds, no code Code: No codes are used on the product REASON: The products contained undeclared egg whites. MANUFACTURER/RECALLING FIRM: Herky's Food Products, Inc., Pittsburgh, PA RECALLED BY: Manufacturer, by telephone on 3/8/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA, OH, and WV QUANTITY: Unknown _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-524-1, Jane's Broccoli Stromboli. The product is a broccoli and cheese strombol sold frozen. CODE: NONE REASON: The product contained undeclared eggs. MANUFACTURER/RECALLING FIRM: Jane's Stromboli, Stoneboro, PA RECALLED BY: Manufacturer, issued a press release on 5/2/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: Western PA QUANTITY: 10987 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-525-1, Newfoods brand of Macapuno Strings packed in 12 oz glass jars; Shipped in cases, 24 jars/case. Products not coded; All product is being recalled. REASON: The products contained undeclared sulfites. MANUFACTURER: Newfoods International Corporation , Phillppines, RECALLED BY: Eastland Food Corp., Columbia, MD, quarantined 220 cases of 12 bottles/cs on 7/24/01 for eventual destruction. The firm contacted all customers who were shipped product since Jan 2000 via phone on 7/24/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY QUANTITY: Macapuno: 38,352 bottles; Sugar Palm: 16,272 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-527-1 Silver Spoon Salads brand Seafood Stuffing, Net Wt. 5 lbs., Item #4595 Code: Date codes 3/18/01 and earlier. REASON: The product contained egg, fish, and wheat ingredients. MANUFACTURER/RECALLING FIRM: Silver Spoon Salad Co., Inc., Chelsea, MA RECALLED BY: Manufacturer, by letter on 3/2/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA, ME, NH, RI, VT QUANTITY: 198/5/lb Seafood Stuffing. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-529-1, Rakestraw's Brand Orange-Pineapple Ice Cream in half gallon cartons dated 3/15/02 Code: Orange-Pineapple Ice Cream, date code 3/15/02 REASON: The product may contain undeclared peanuts. MANUFACTURER/RECALLING FIRM: GARBER ICE CREAM CO., Winchester, VA RECALLED BY: Manufacturer, by press release to AP Harrisburg on 5/25/2001 for coverage by the Pennsylvania wire. FIRM INITIATED RECALL: Complete DISTRIBUTION: Approximate radius of 25 miles of Mechanicsburg, PA QUANTITY: 297 gallons _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-530-1, Jungle Jammers Brand Animal Crackers, The product is a cookie that is sold in 13 oz boxes and shipped 12 boxes per case, Code dates: 01302C, 02012A, 02012B, 02232B, 02232C, 02242A, 03062B. REASON: The product contained undeclared milk and eggs. MANUFACTURER/RECALLING FIRM: D F Stauffer Biscuit, York, PA RECALLED BY: Manufacturer by press release on 6/11/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, FL, GA, IN, KY, MD, MI, MO, NY, OH, TN, & TX QUANTITY: 8168 cases (98,016 units) ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-535-1, Sliced apples in poly bags labeled in part "CRUNCH PAK ** Fresh Sliced Apples ** Net Wt. ** Fresh Products Northwest 3907-10 Chelan Hwy Wenatchee, WA 98801 ***". The 6.75 oz. package that contains the caramel is labeled as above, plus "with Caramel" on the front pane. All apple varieties are included. The 6.75 oz. package contains 6 oz. of sliced apples and a .75 oz. package of caramel. Product is packaged as follows: 2 oz./32 pkgs & 64 pkgs/case 6 oz. & 6.75 oz./12 & 30 bags/case 1 lb./12 pkgs/case 3 lb./4 pkgs/case 30 lb./case REASON: The product was contaminated with Listeria monocytogenes. MANUFACTURER: Fresh Products Northwest, Wenatchee, WA RECALLED BY: Fresh Products Northwest, Medford, OR, on 3/23/01, by faxed letters, and telephon on 3/23,24,&26/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: Approx. 54,000 lbs. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-536-1, Apple slices with caramel packets in clear plastic trays, label affixed to the bottom of tray reads in part "Apple Tray 50 oz" or "Apple Snack 16 oz", both labeled with "Ingredients: granny smith and gala apples and caramel dip. Use by ** Dist. by: Duck Delivery Portland, OR 97211". Code Information: "USE BY 4/11/01" and prior REASON: Apple Slices Contaminated with Listeria Monocytogenes MANUFACTURER/RECALLING FIRM: Duck Delivery Produce, Inc., Portland, OR RECALLED BY: Manufacturer, by telephon on 3/24/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: WA, OR, ID, OR. QUANTITY: 244 cases of 6/16 oz. containers, 240 cases/ of 2/50 oz. containers _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-537-1, Chicken salad sandwich in a MAP rigid plastic wedge pack with a flex plastic overwrap labeled in part "CHICKEN SALAD JUMBO FOODS MUKILTEO WA ** LUNCHBOX CHICKEN SALAD **". Code:A041601 REASON: The product was contaminated with Listeria monocytogenes. MANUFACTURER/RECALLING FIRM: Jumbo Foods Inc., Mukilteo, WA RECALLED BY: Manufacturer, by visit on 4/12&13/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: WA, OR, AZ and possibly in ID, UT, NM and CA QUANTITY: 1809 sandwiches _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-538-1, Fresh Line brand Apple Platter, 24 oz., refrigerated, packaged by Fresh Line, Indianapolis, IN 46226. The platter is a round plastic tray with apple slices and a caramel dip in the center. The product is packaged in 4/24 oz. platters per case. REASON: Listeria Monocytogenes contamination. Apple slices received were contaminated with Listeria Monocytogenes. MANUFACTURER/RECALLING FIRM: Caito Foods Service, Inc., Indianapolis, IN RECALLED BY: Manufacturer, by telephone on 3/23/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY: Out of 122 cases of the product (30 lbs. per case), the firm repackaged 70 cases of sliced apples into 1400, 24oz. platters which were distributed. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-539-1, Sliced apples in 3 & 6 oz. poly bags labeled in part:”FRESH CUT PRODUCE FIELDERS Choice ***Apple-Snax 6oz. Sweet Apples Fielder’s Choice Produce, Inc., Phoenix, AZ 4” and “FRESH CUT PRODUCE FIELDERS Choice *** Apple-Snax 3oz., Sweet Apples Fielder’s Choice Produce, Inc., Phoenix, AZ REASON: The product was manufactured using sliced apples RECALLED BY Fresh Products Northwest LLC, Medford, OR due to Listeria monocytogenes contamination. MANUFACTURER/RECALLING FIRM: Fielder's Choice, Phoenix, AZ RECALLED BY: Manufacturer, on March 26, 2001, by fax and by visit. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 30 cases (450 lbs sliced tart and 450 lbs. sliced sweet) ______________________________ RECALL NUMBER, PRODUCT AND CODE: 4 ounce ready to eat sandwiches of the following varieties: F-540-1 Luncheon Meat F-541-1 Smoked Turkey F-542-1 Smoked Turkey Salad F-543-1 Sliced Smoked Chicken Breast F-544-1 Ham & Cheese F-545-1 Sliced Turkey All products are sold as individual units packaged in rigid triangular shaped plastic with a flexible plastic over-wrap showing the cut side of the sandwich. Code: Sell By May 1, 01 REASON: The products were contaminated with Listeria monocytogenes. MANUFACTURER/RECALLING FIRM: The Sandwich Man, Inc., Pearl River, LA RECALLED BY: Firm's drivers (delivery persons) were given a list of sandwiches to be recalled and they pulled them from the customers shelves by 4/27/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: Louisiana and the Gulf Coast of Mississippi QUANTITY: 681 sandwichesRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-468-1 Yellow Food Coloring F-469-1 Green Food Coloring F-470-1 Banana Creme Flavoring Product Details: Yellow Food Color, Catalogue No. FOO-321, 18gm and 3gm Green Food Color, Catalogue No. FOO-316, 18gm, 3gm Banana Crème Flavor, Catalogue No. FLA-208, 120mL, 500mL and 30mL Code: All product shipped between January 19, 2000 - March 8, 2001 REASON: The products contain undeclared FD&C; Yellow No. 5. MANUFACTURER/RECALLING FIRM: Meridian Pharmaceuticals, Inc., Decatur, AL RECALLED BY: The firm became aware of the recall situation from an inspection performed on 2/21-22 7 3/5-7/01. Correction of in stock items began on 3/8/01. The firm sent out its recall notifications on 4/6/01 and 4/9/01 via US Mail. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: Yellow Food Color – 31/3 gm and 32/18 gm, Green Food Color – 39/3 gm and 35/18 gm, Banana Crème Flavor – 11/30 mL, 5/120 mL and 1/500 mL _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-526-1 Newfoods brand of Sweet Sugar Palm, packed in 12 oz. glass Shipped in cases, 24 jars/case. REASON: The products contained undeclared sulfites. MANUFACTURER>: Newfoods International Corporation , Phillppines, RECALLED BY: Eastland Food Corp., Columbia, MD, quarantined 220 cases of 12 bottles/cs on 7/24/01 for eventual destruction. The firm contacted all customers who were shipped product since Jan 2000 via phone on 7/24/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY QUANTITY: Macapuno: 38,352 bottles; Sugar Palm: 16,272 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-528-1 Silver Spoon Salads brand Seafood Salad, Net Wt. 5lbs., Item #4509 Code: Date codes 3/18/01 and earlier. REASON: The product contained undeclared wheat. MANUFACTURER/RECALLING FIRM: Silver Spoon Salad Co., Inc., Chelsea, MA RECALLED BY: Manufacturer, by letter on 3/2/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA, ME, NH, RI, VT QUANTITY: 572/5 Lb.Seafood Salad. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-531-1, Shary(R) brand Cream Cake Cantaloupe, a soft cake, packaged in flexible plastic containers, net wt. 150 grams, 16 - 150 gram pkgs. per case. Product of China. Code: Barcode# 6 909588 012068 and no other coding. REASON: The product contained the undeclared and unapproved color additive tartrazine (certifiable as FD&C; Yellow No. 5). MANUFACTURER/RECALLING FIRM: Shanghai G.T. Nission Food Co. Ltd., Shanghai, China RECALLED BY: Strong America Limited, Brooklyn, NY , by "Recall Notice", dated 10/2/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY and FL QUANTITY: 107 cases (16 - 150 gram packages per case) were distributed. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-532-1, Goldensmell brand Shanzha Bing (Haw Flakes) packaged in flexible plastic containers, net wt. 11 grams, 120 - 11 gram pkgs. per case. Product of China. Code:None. REASON: The product contained undeclared Ponceau 4R (E124, Acid Red 18), an unapproved color additive. MANUFACTURER/RECALLING FIRM: Shan Dong Zhaoyuan Huatuan Fruit Co., Shan Dong City, P.R. of China, RECALLED BY: Strong America Limited , Brooklyn, NY, by "Recall Notice", dated 8/5/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY, FL, NC, TN and MA. QUANTITY: 163 cases (120 - 11 gram packages per case) were distributed; 37 cases were seized by NYSDAM on 8/1/00. 54 cases were recovered from the direct accounts. A total of 91 cases were returned to China (9/2000). _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-534-1, Kingdom brand No. 1 Konnyaku Coconut Jelly packaged in rigid plastic jars, net wt. 53 oz. (1500 g), 6 - 53 oz. jars per case. Code Information: Barcode# 0 31898 88807 4 and no other coding. REASON: The product contained undeclared tartrazine (certifiable as FD&C; Yellow No. 5), an unapproved color additive. MANUFACTURER: Yeang Sheng Enterprise Co. , Lukang Town, Taiwan, RECALLED BY: Strong America Limited, Brooklyn, NY, by letter. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY, FL, TN, MA and IL. QUANTITY: 37 cases (6 - 53 oz. jars per case) were distributed.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-533-1, Extra Strength Oyster Shell Calcium 500 mg., 100's under the Discount Drug Mart label. REASON: Incorrectly labeled One Daily Men's Formula 100's. MANUFACTURER/RECALLING FIRM: Leiner Health Products Inc., Fort Mill, SC RECALLED BY: Leiner Health Products,Carson, CA, by letter on March 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 1,896 bottles were distributed RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-290-1, Fluocinolone Acetonide Ointment USP, 0.025%, in 15 gram and 60 gram tubes, distributed under the E. Fougera & Co. label. CODE: Lot G018, expiration date January 2003. 15 g tubes: NDC 0168-0064-15, 60 g tubes: NDC 0168-0064-60 REASON: Lack of Homogeneity Leading to Super-Potency.. MANUFACTURER: Altana Inc., Hicksville, NY RECALLED BY: Altana Inc., Melville, NY, by letter, dated 8/7/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 24,991 - 15 g tubes and 22,740 - 60 g tubes were distributed _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-291-1, LORAZEPAM Tablets, USP, 0.5mg, NDC #61392-455-39, packaged as 30 tablets per 'bingo' card, 140 cards per case. Code: Lot Number: 18291 Exp Date: 5/31/2003 REASON: CONTAINER DEFECT; The plastic material used to repackage the individual tablets is de-laminating. MANUFACTURER/RECALLING FIRM: Geneva Pharmaceuticals, Broomfield, CO RECALLED BY: Heartland Repack Services, Toledo, OH, on 8/3/2001, by letter. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 10,588 cards _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-292-1, Oxygen, USP, compressed medical gas, sold in "E" Cylinders, Lot 193SFS10181 REASON: Partially filled and/or empty cylinders released for sale. MANUFACTURER/RECALLING FIRM: Air Liquide America Corporation, Houston, TX RECALLED BY: Manufacturer, by visits on July 18th and 19th, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 88 cylindersRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-270-1, Yellow Rockets Tablets, 200 mg Caffeine. The product is sold in 100 count, 250 count, and 500 count bottles. The label states that the product is manufactured for T&M; Distributors, Council Bluff, IA. Code: Lot 10293 exp. 2/03 REASON: STABILITY: There is no Data to support labeled EXPIRY DATE MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals, Inc., Milroy, PA RECALLED BY: Manufacturer, by letter on 6/27/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IA QUANTITY: 1083 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-271-1, Overtime Stimulant tablets, 200 mg caffeine The product is sold in 100 count and 500 count bottles. The label states that the product is distribured by BDI Pharmaceuticals, A Division of Body Dynamics Inc, Carmel, IN. Lot 6085 exp. 7/01 and Lot 10362 exp. 2/03 REASON: STABILITY: There is no Data to support LABELED EXPIRY DATE MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals, Inc., Milroy, PA RECALLED BY: Manufacturer, by letter dated 6/27/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IN QUANTITY: 125 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-276-1, Monsel Solution (Ferric Subsulfate Solution). The product is sold in an 8 ml vial in cases of 12 vials. The NDC number is 48783-112-08. Code: Lot #57952 exp. 1/02 REASON: SUPER-POTENT FOR IRON CONTENT MANUFACTURER: Dercher Enterprises Inc., Darby, PA RECALLED BY: Premier Medical Products, King of Prussia, PA, by letter dated 9/28/00 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, CT, IA, IL, IN, MD, ME, MI, MN, MO, ND, NY, OH, PA, and WA QUANTITY: 450 dozenRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1331-1, Red Blood Cells, Unit KK14666 REASON: Blood product, collected in a bag that may have had a puncture hole, was distributed. MANUFACTURER/RECALLING FIRM: Sacramento Medical Foundation Blood Center, Sacramento, CA RECALLED BY: Manufacturer, by telephone, on May 28, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1614-1, Carticel (Autologous Cultured Chondrocytes) , Lot CC00335 REASON: Tissue repair product, contaminated with Corynebacterium, was distributed. MANUFACTURER/RECALLING FIRM: Genzyme Biosurgery , Cambridge, MA RECALLED BY: Manufacturer, by telephone on April 24, 2001, and by letters dated April 24, 2001 and May 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Norway QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1736-1, Corneas for Transplant, Tissue ID # 01-0637, 01-0638 REASON: Corneas, from a donor who tested reactive for the HIV p24 antigen, with a negative Western Blot, by another donor procurement organization, were distributed. MANUFACTURER/RECALLING FIRM: Georgia Eye Bank, Inc., Atlanta, GA RECALLED BY: Manufacturer, by telephone and letters on May 30, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: GA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1737-1, Red Blood Cells, Unit 5074564 B-1738-1, Platelets, Unit 5074564 B-1739-1, Recovered Plasma, Unit 5074564 REASON: Blood products, which tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, with a negative confirmatory test, were distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: Manufacturer, by letters dated March 17, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas and Switzerland QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1745-1, Platelets, Pheresis, Unit 1662747 REASON: Blood product, collected from a donor who may have traveled to an area designated as endemic for malaria, was distributed MANUFACTURER/RECALLING FIRM: Blood Center of New Jersey, Inc., East Orange, NJ RECALLED BY: Manufacturer, by letter dated January 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NJ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1757-1, Red Blood Cells, Leukoreduced, Unit 0331587 REASON: Drug product, collected from a donor whose spouse had a history of intravenous drug use, was distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas, Kansas City, MO RECALLED BY: Manufacturer, by letter dated April 18, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MO QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1766-1, Red Blood Cells, Unit 38L59729 B-1767-1, Recovered Plasma, Unit 38L59729 REASON: Blood products, collected from a donor with a history of jaundice, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Fort Wayne, IN RECALLED BY: Manufacturer, by facsimile on April 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, NY QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1772-1, Red Blood Cells, Unit E12522 REASON: Autologous Red Blood Cells, which tested repeat reactive for anti-HCV, with a negative RIBA, was not labeled with a Biohazard label. MANUFACTURER/RECALLING FIRM: St. Elizabeth Health Center, Youngstown, OH RECALLED BY: Manufacturer, by telephone on May 13, 2001, and by facsimile on May 17, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1778-1, Corneas for Transplant, Tissue ID numbers: 99-085(OD), 99-086 (OS), 99-333 (OD), 99-334 (OS), 99-431 (OD), 99-432 (OS), 99-0565 (OD), 99-0566 (OS), 99-0735 (OD), 99-0736 (OS), 00-003 (OD), 00-004 (OS), 00-0239 (OD), 00-0240 (OS) REASON: Corneas, from donors who tested repeatedly reactive for either anti-HBc, CMV, HBsAg, and/or the HIV p24 antigen, by another donor procurement organization, were distributed. MANUFACTURER/RECALLING FIRM: Lions Eye Bank of Central Texas, Austin, TX RECALLED BY: Manufacturer, by letters dated May 3, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, TX and MO QUANTITY: 14 _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1780-1, Reagent Red Blood Cells; Surgiscreen; Lot # 3SS223; Expiration: 6 February, 2001. REASON: Reagent red blood cells (1, 2 and 3), may lack the E antigen necessary for antibody detection. MANUFACTURER/RECALLING FIRM: Ortho Clinical Diagnostics, Raritan, NJ RECALLED BY: Manufacturer, by letters dated January 19, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Japan QUANTITY: 402 packages ______________________________ RECALL NUMBER,PRODUCT AND CODE: B-1783-1, Corneas for Transplant, Donor ID #2001-06-3061, 2001-06-3062 REASON: Corneas, from a donor who tested repeat reactive for anti-HBc, were distributed. MANUFACTURER/RECALLING FIRM: Heartland Lions Eye Banks, Columbia, MO RECALLED BY: Manufacturer, by telephone on July 16, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Missouri QUANTITY: 2 Units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1784-1, Corneas for Transplant, Donor ID #2001-06-3051, 2001-06-3052 REASON: Corneas, from a donor who tested repeat reactive for anti-HBc, were distributed. MANUFACTURER/RECALLING FIRM: Heartland Lions Eye Banks, Columbia, MO RECALLED BY: Manufacturer, by telephone on July 6, and July 9, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: MO and Cincinnati QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1791-1, Red Blood Cells, Unit 1635942 B-1792-1, Cryoprecipitate Reduced Plasma, Unit 1635942 B-1793-1, Cryoprecipitate AHF, Unit 1635942 B-1794-1, Platelets, Unit 1635942 REASON: Blood products, collected from a donor with a history of having tested positive for Hepatitis C, were distributed. MANUFACTURER/RECALLING FIRM: South Texas Blood & Tissue Center, San Antonio, TX RECALLED BY: Manufacturer, by letter dated July 26, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1795-1, Red Blood Cells, Units H82822, H84757 REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Regional Health Resource Center, Urbana, Illinois RECALLED BY: Manufacturer, by telephone on May 2, 2001, and by letter dated May 17, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1796-1, Red Blood Cells, Unit 7000902 REASON: Blood product, collected from a donor whose hemoglobin had not been documented, was distributed. MANUFACTURER/RECALLING FIRM: New York Blood Center, Elmsford, NY RECALLED BY: New York Blood Center (Center West), New York, NY, by letter dated June 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1797-1, Source Plasma Units 0024973, 0029810, 0031062, 0034881, 0036101, 0037516, 0025336, 0030000, 0035083, 0036514, 0037937, 0028849, 0030473, 0034258, 0035476, 0036639, 0038126, 0029256, 0030676, 0034459, 0035911, 0037228 (22 units) REASON: Blood products, collected from a donor who had an accidental mucous membrane exposure to blood, were distributed. MANUFACTURER/RECALLING FIRM: DCI Biologicals, Wichita Falls, Inc., Wichita Falls, TX RECALLED BY: Manufacturer, through a New York broker, by letter dated December 20, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Vienna QUANTITY: 22 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1798-1, Red Blood Cells, Leukoreduced, Unit 16LY91798 B-1799-1, Fresh Frozen Plasma, Unit 16LY91798 REASON: Blood product, collected from a donor with a history of having tested positive for Hepatitis C, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Columbus, OH RECALLED BY: Manufacturer, by letters dated June 4, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1800-1, Red Blood Cells, Unit 7028859 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Department of the Air Force, Keesler Air Force Base, MS RECALLED BY: Manufacturer by letter dated February 15, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MS QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1806-1, Red Blood Cells, Leukoreduced, Unit FG64423 REASON: Blood product, which were mislabeled as CMV antibody negative, was distributed. MANUFACTURER: Central Blood Bank, Pittsburgh, PA RECALLED BY: Institute for Transfusion Medicine Clinical Services, Pittsburgh, PA, by telephone on June 25, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1808-1, Platelets, Pheresis, (Part II) Unit 0811723 REASON: Blood product, which had a high platelet count, was distributed. MANUFACTURER/RECALLING FIRM: Blood Centers of the Pacific, San Francisco, CA RECALLED BY: Manufacturer, by telephone on April 3, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1809-1, Platelets, Pheresis, Leukoreduced, Unit 0802164 REASON: Blood product, collected from a donor who had a tattoo within twelve months of donation, was distributed. MANUFACTURER/RECALLING FIRM: Blood Centers of the Pacific, San Francisco, CA RECALLED BY: Manufacturer, by letter dated June 17, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1810-1. Red Blood Cells, Unit 04N90126 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Dedham, MA RECALLED BY: Manufacturer, by letter dated April 4, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1811-1, Red Blood Cells, Unit 04KK38740 REASON: Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed MANUFACTURER/RECALLING FIRM: American Red Cross, New England Region, Dedham, MA RECALLED BY: Manufacturer, by letter dated April 13, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: VT QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1812-1, Red Blood Cells, Unit 04FR43766 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, New England Region, Dedham, MA RECALLED BY: Manufacturer, by letter dated May 8, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1815-1, Red Blood Cells, Irradiated, Leukoreduced, Unit C43197 REASON: Blood product, for which documentation of irradiation was incomplete, was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Aurora, IL RECALLED BY: Manufacturer, by letter dated June 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1816-1, Red Blood Cells, Unit 6756870 REASON: Blood product, collected from a donor who had traveled to an area designated as endemic for malaria, was distributed MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers, Lake Charles, LA RECALLED BY: Manufacturer, by letter dated March 15, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1817-1, Red Blood Cells, Unit 9520966 B-1818-1, Recovered Plasma, Unit 9520966 REASON: Blood product, collected from a donor whose partner had lived in an area at increased risk for HIV Group O, was distributed. MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers, Lake Charles, LA RECALLED BY: Manufacturer, by facsimile on November 6, 1998, and letter on December 2, 1998, FIRM INITIATED RECALL: Complete DISTRIBUTION: TX and CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1819-1, Red Blood Cells, Unit 9514753 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers, Lake Charles, LA. RECALLED BY: Manufacturer, by telephone on April 14, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: LA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1822-1, Source Plasma, Units 27721766, 29710898 REASON: Blood products, which tested positive for syphilis, were distributed. MANUFACTURER/RECALLING FIRM: Sera-Tec Biological Limited Partnership, Odessa, Texas RECALLED BY: Manufacturer, by letter dated October 23, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1828-1, Cephalothecium (ALK), Trichothecium roseum, Lot B1016179 REASON: Allergenic extract labeled as Cephalothecium (ALK), Trichothecium roseum, 10 M/L 1:20 w/v, was prepared from Cephalosporium acremonium (ALK), 1:20 w/v. MANUFACTURER/RECALLING FIRM: Allergy Laboratories of Ohio, Inc., Columbus, OH RECALLED BY: Manufacturer, by telephone on April 6, 2001, and by facsimile on April 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY: 1 lot _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1830-1, Platelets, Unit 3922122 REASON: Blood product, collected from a donor who had a history of high risk behavior, was distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, Texas RECALLED BY: Manufacturer, by fax dated November 30, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1831-1, Red Blood Cells, Unit 03S06681 B-1832-1, Recovered Plasma, Unit 03S06681 REASON: Blood product, collected from a donor who had a history of high risk behavior, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Atlanta, GA RECALLED BY: Manufacturer, by telephone on April 11, and letter dated April 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: VA QUANTITY: 2 unitsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1473-1, Red Blood Cells, Units 15009-0540, 15006-9967 B-1474-1, Fresh Frozen Plasma, Units 15009-0540, 15006-9967 REASON: Blood products, collected from an ineligible donor with a history of Crohn’s disease, were distributed. MANUFACTURER: United Blood Services, Texas Blood Institute - Lubbock Center, Lubbock, TX RECALLED BY: Blood Systems, Incorporated, Scottsdale, AZ, by telephone, on June 27, and June 28, 2000, and by letter, dated August 4, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 4 Units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1781-1, Red Blood Cells Unit 22414-9241 REASON: Blood product, was distributed after the donor reported having developed Herpes Simplex the night following the donation. MANUFACTURER: United Blood Services, Las Vegas, NV RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1790-1, HIV p24 Antigen Test Kit, Lots 7288M201, 75339M101 REASON: HIV p24 test kits exhibit an initial reactive rate, which is higher than the initial reactive rate documented in the package insert. MANUFACTURER/RECALLING FIRM: Abbott Laboratories,Abbott Park, IL RECALLED BY: Manufacturer, by letters dated 5/7/01, and telephone on May 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 698 kits were distributed _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1801-1, Red Blood Cells, Units R34824, R34827, R34829, R34831, R34832 REASON: Blood products, labeled with extended expiration dates, were distributed. MANUFACTURER/RECALLING FIRM: San Diego Blood Bank, San Diego, CA RECALLED BY: Manufacturer, by telephone on June 8, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1802-1, Red Blood Cells, Leukoreduced (Pheresis), Split Units 15386-7710, 15386-7724, 15386-8007. (The 1st bag was distributed under product code 04741 and the 2nd bag under product code 04761). REASON: Blood products, which were stored at unacceptable temperatures, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Midland, TX RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 12, 2001, and by letters dated April 5, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas QUANTITY: 6 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1803-1, Platelets, Unit 7837039 B-1804-1, Cryoprecipitate, Unit 7517935 B-1805-1, Fresh Frozen Plasma, Unit 7837039 REASON: Blood products, prepared from Whole Blood units that had discrepant start and end times documented, were distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: Manufacturer by letters dated January 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1807-1, Red Blood Cells, Leukoreduced, Unit KJ36832 REASON: Red Blood Cells, leukoreduced by filtration greater than five days past the time of collection, was distributed. MANUFACTURER: Central Blood Bank, Pittsburgh, PA RECALLED BY: Institute for Transfusion Medicine Clinical Services, Pittsburgh, PA, by telephone on May 31, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1813-1, Red Blood Cells, Leukocyte Reduced, Unit C30023 REASON: Blood product, which was stored at unacceptable temperatures, was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: Manufacturer, by letter dated June 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 Unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1814-1, Red Blood Cells, Unit C42273, C42893 REASON: Blood products, which may have been stored at unacceptable temperatures, were distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: Manufacturer, by letter dated June 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY: 2 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-919-1 to Z-921-1, Revo Scooter. The product is a three wheeled motorized scooter. The product has been designed for both indoor and outdoor use to clean and dry conditions. Model Information: SC60RRED, SC60RBLU, and SC60RYEL Models: SC60RRED (red), SC60RBLU (blue), and SC60RYEL (yellow) REASON: Scooter drive system may engage while parking brake is inactive. MANUFACTURER: Shanghai Global Fabtech Plastic Products, Shanghai, China, RECALLED BY: Pride Mobility Products Corp, Exeter, PA, issued a safety alert to all dealers/distributors utilizing product warranty cards and dealer assistance, on 5/18/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY: 1152 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-976-1, Ash Split Catheter with cuffs, Batch/Lot #: M001110, M006670, M006680, M006690, M007880, M017830, M903530, M906960, M907290, M907320, M908140, M909720, M911390, M911400, M911710, M911980, M912050, M912590, M913080, M913420, M913860, M914060, M914390, M914490, M914840, M916110, M917050, M918100, M918830, M918840, M918990, M919670, M920140, M920980, M921130, M921580, M922000, M922140, M922680, M923000, M926000, M926340, M926450, M930130, M930770, M930940, M931050, M931150, M931170, M931340, M931350, M931490, M931860, M932390, M932760, M932790, M932850, M933510, M933900, M934630, M935280, M936300, M940830, M942910, M943310, M944490, M909620, M914150, M916830, M932280, M912760, M932290, M003070, M005720, M008290, M011110, M011680, M014600, M019810, M021120, M914070, M914670, M916400, M916980, M918110, M918310, M918580, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M930680, M931360, M931480, M931810, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M006680, M006690, M903530, M911710, M911980, M912050, M913080, M914390, M914840, M918830, M918990, M919670, M921130, M922000, M922140, M922310, M922680, M923000, M926000, M926450, M927660, M931340, M931350, M931860, M932390, M932850, M933900, M935280, M936300, M940830, M944490, M912670, M921200, M923100, M005720, M916400, M918310, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M927500, M931360, M931480, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M923110, M914390, M002820, M007890, M904270, M911580, M913500, M914660, M915210, M922730, M925310, M926940, M929410, M931600, M932770, M935790, M942900, M004950, M009190, M918120, M920020, M922740, M924030, M925320, M927270, M932780, M936450, and M918310. REASON: Catheter fails to remain anchored to patient. MANUFACTURER/RECALLING FIRM: Medical Components, INC., Harleysville, PA. RECALLED BY: Manufacturer, in 11/99, by letter to the dialysis centers instructing them to permanently secure the catheter to the skin to prevent dislodgement. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 43292RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Recall # Product V-397-1 Hyland Floating Fishfood, in 50 pound bags V-398-1 Endurance Plus Extrude Horse Feed, in 50 pound bags V-399-1 Seminole Ultra Bloom Horse Feed, in 50 pound bags V-400-1 Wheat Flakes, extruded product in bulk, not bagged V-401-1 Corn Flakes, extruded product in bulk, not bagged V-402-1 Capt. Crunch, extruded product in bulk, not bagged V-403-1 Green Corn Puffs, extruded product in bulk, not bagged V-404-1 Orange Corn Puffs, extruded product in bulk, not bagged V-405-1 Whole Kernel Corn, in 50 pound bags, unlabeled V-406-1 Soybean Meal, in bulk, not bagged, unlabeled ALL CODES REASON: The animal feed products may contain proteins derived from mammalian tissues. The products are not labeled with the required BSE caution statement "Do Not Feed to Cattle or Other Ruminants." MANUFACTURER/RECALLING FIRM: The Hyland Company, Ashland, Kentucky RECALLED BY: Manufacturer, by telephone on July 25, 2001, and letters on July 31, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: KY, GA, NC, FL WV QUANTITY: 568 tonsEND OF ENFORCEMENT REPORT FOR August 29, 2001. ####
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