November 21, 2001 01-46
RECALLS AND FIELD CORRECTIONS: FOODS CLASS I
_______________________ PRODUCT Dietary supplement in bottle labeled in part "Opti Gest 1 A Dietary Supplement ** Each Capsule contains: Betaine Hydrochloride...648 mg Pepsin....130 mg ** Eclectic Institute, Inc. Sandy, Oregon”, Recall # F- 040-2. CODE 4902 RECALLING FIRM/ MANFACTURER Eclectic Institute, Inc., Sandy, OR, by telephone on 5/17/01. Firm initiated recall is complete. REASON The product was manufactured using pepsin at American Laboratories, Inc., Omaha, NE recalled due to Salmonella contamination. PRODUCT 45/100 cap bottles, 31/250 cap bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Darigold brand "Totally Chocolate" flavor ice cream in half gallon size. Labeled in part "DARIGOLD Totally Chocolate Ice Cream***5321 01173***", Recall # F-041-2. CODE "5321 01173 XXXX" 5321 is the plant code; 01173 is the Julian code; XXXX is for the time code. All time codes for "5321 01173" are being recalled. RECALLING FIRM/ MANFACTURER Recalling Firm: Darigold, Inc. (d.b.a. WestFarm Foods) Seattle, WA, by press release and memo on 7/31/01. Firm initiated recall is complete. Manufacturer: WestFarm Foods Seattle, WA. REASON Product may contain undeclared walnuts. PRODUCT 5802 half gallons. DISTRIBUTION WA, OR, ID, and CA. _______________________ PRODUCT Product: Karuna brand HCL (Betaine HCl, Glutamic HCl, and Pepsin), 100/100mg capsules in a vial, Recall # F-042-2. CODE The lot # is stamped in black ink on the bottom right hand side of the label as follows: “0104602 02/04”. RECALLING FIRM/ MANFACTURER Recalling Firm: Karuna Corporation, Novato, CA, by letter and press release on 5/17/01. Manufacturer: Health Wright Products, Inc. Clackamas, OR. Firm initiated recall is complete. REASON The product was manufactured using pepsin that American Laboratories, Inc., Omaha, NE recalled due to Salmonella contamination. PRODUCT 63 vials (100/100mg Pepsin). DISTRIBUTION CA, AZ, OR, MN, and WI. _______________________ PRODUCT a) 100% Hass Avacado Pulp; 6 lbs bag, Recall # F-043-2 b) 100% Hass Avacado Chunks; 6 lbs. bag, Recall # F-044-2 CODE a) Avacado Pulp Date Coded "DEC 05 2000"; b) Avacado Chunky Date Coded "JAN 17 2001"; b) Avacado Chunky Date Coded “JAN 30 2001.” RECALLING FIRM/ MANFACTURER Recalling Firm: G. Products, Inc. San Diego, CA, by telephone on 2/9/01. a) Manufacturer: Epansa de C.V. Exp. Y Procesadora De Alimentos Mexicanos/Alamo Tijuana, BC, Mexico. b) Manufacturer: Comisa De CV/Caborca Tijuana, BC, Mexico. Firm initiated recall is complete. REASON The products were contaminated with Listeria monocytogenes. PRODUCT 250 bags. DISTRIBUTION Southern CA. _______________________ PRODUCT Orange Sherbet, bulk 2 and 1/2 gallon containers, Recall F-045-2. CODE No lot numbers. RECALLING FIRM/ MANFACTURER Mauel's Dairy, Inc., Owen, WI, conducted store visit on March 30, 2001. Firm initiated recall is complete. REASON Undeclared eggs. PRODUCT Undetermined. DISTRIBUTION WI. _______________________ PRODUCTFood Lion Fudge Royale half gallon size ice cream, distributed by Food Lion, LLC Salisbury, NC. Recall # F-048-2. CODE Code date 041202#1 3783 1902 to 2200. RECALLING FIRM/ MANFACTURER Dairy Fresh, LLC., Winston-Salem, NC, by fax on 8/23/01. Firm initiated recall is complete. REASON Ice Cream contains undeclared peanuts. PRODUCT 8088 packages. DISTRIBUTION DE, FL, GA, KY, MD, NC, PA, SC, TN, VA, WV. _______________________ PRODUCT Marie Callender's Complete Dinner Breaded Fish with Macaroni and Cheese and Broccoli Florets, net wt. 12 oz., 8 packages per case. Recall # F- 050-2. CODE 14E1206; 14F1206; 14G1206; 14H1206. RECALLING FIRM/ MANFACTURER Recalling Firm: MC Retail Foods Omaha, NE, via phone and e-mail on 9/10- 11/01. Manufacturer: ConAgra Frozen Prepared Foods Council Bluffs, IA. Firm initiated recall is complete. REASON Undeclared egg whites. PRODUCT 4,366/8-package cases. DISTRIBUTION Nationwide.
RECALLS AND FIELD CORRECTIONS: FOODS CLASS II
_______________________ PRODUCT MeadowCroft Farm brand, Old Fashioned, Lime Pickles, packed in 12 ounce glass jars, 12 jars per case, Recall # F-036-2. CODE Date codes 03310, 03511, 03702. RECALLING FIRM/ MANFACTURER Meadowcroft Farm Swoope, VA, by letter on 10/20/2001 and on 10/22/2001. Firm initiated recall is complete. REASON Product contained undeclared FD&C Yellow No.5 and Blue No.1 color additives. PRODUCT 115 jars. DISTRIBUTION VA and FL. _______________________ PRODUCT “DanDee Cuban Melt”, a prepared refrigerated sandwich in a clear plastic bag with a stick on label, Recall # F-038-2. CODE Expiration date of 7/12/01 or earlier. RECALLING FIRM/ MANFACTURER Dandee Foods, Jacksonville, FL, by onsite visit, between 7/2/01 and 7/12/01. Firm initiated recall is complete. REASON Label fails to declare FD&C Yellow No.5. PRODUCT 4000. DISTRIBUTION FL, AL and GA. _______________________ PRODUCT a) Mauel's Premium Sunshine Green Mint Ice Cream, in container sizes of bulk 2 1/2 gallons, gallons, 1/2 gallons, and quarts, Recall # F-046-2. b) Mauel's Premium Sunshine Chocolate Chip Mint Ice Cream, in container sizes of bulk 2 1/2 gallons, gallons, 1/2 gallons and quarts, Recall # F-047-2. CODE No lot numbers. RECALLING FIRM/ MANFACTURER Mauel's Dairy, Inc. Owen, WI, conducted store visit on March 30, 2001. Firm initiated recall is complete. REASON a) Green Mint Ice Cream - undeclared Yellow No. 5; b) Choc. Chip Mint Ice Cream - undeclared Yellow No. 5. REASON Undetermined. DISTRIBUTION WI. _______________________ PRODUCT Caffeine Free Coca-Cola Classic in 2 liter Plastic Bottles. Recall # F-049-2. CODE All 2 liter Caffeine Free Diet Coke product with the date code of "082001HWA06:00 through 07:30". RECALLING FIRM/ MANFACTURER Recalling Firm: Coca Cola Bottling Co. Hollywood, FL, by letter on June 7, 2001. Firm initiated recall is complete. REASON The product, labeled as "Caffeine Free Diet Coke", actually contained "Caffeine Free Coca Cola." PRODUCT 275 cases (12 per case). DISTRIBUTION South FL.RECALLS AND FIELD CORRECTIONS: FOODS CLASS III
_______________________ PRODUCT Smoked sturgeon in 7 oz. cans labeled in part "Product of Canada, Packed for Port Chartham Packing Co. ** Seattle, WA **Smoked Sturgeon Net Wt. 7 OZ. Recall # F-037-2. CODE DM420/32AC, DM420/42AC, DM421/31AC, DM421/41AC, DM422/11AC, DM422/21AC, DM422/31AC. RECALLING FIRM/ MANFACTURER Recalling Firm: Icicle Sea Foods Inc Seattle, WA. Manufacturer: Great Northern Packing Ltd. Canada, by telephone on 12/21/00. Firm initiated recall is complete. REASON The product was unfit for food due to being held in swollen and leaking containers. PRODUCT 1895 cans. DISTRIBUTION Seattle, WA area. _______________________ PRODUCT Felpausch brand Chunk Light Tuna in water, 6 oz cans, Recall F-039-2. Distributed by: Felpausch Food Centers, Hastings, MI. Product of Papua, New Guinea. CODE RDSCV50017, RDSCV50019, RDSCV50020. RECALLING FIRM/ MANFACTURER Felpausch Food Centers, Hastings, MI, by telephone on 6/25/01 and by press release on 6/26/01. The firm initiated recall is complete. REASON Some cans are flippers and may be overfilled. Can-seam integrity may be compromised. PRODUCT 90,000 cans were distributed. 64,560 cans were returned from the stores. DISTRIBUTION MI and northern IN.RECALLS AND FIELD CORRECTIONS: DRUGS CLASS II
_______________________ PRODUCT Meperidine Hydrochloride Injection, USP 10 mg/mL, 30 mL (PCA Vial) NDC 0074-46030-04, Rx only, Recall # D-035-2. CODE Lot Numbers and Exp. Dates. 69-226 DK, 01 APR 2002; 72-515 DK, 01 JUL 2002; 72-389 DK, 01 JUL 2002; 73-117 DK, 01 AUG 2002; 73-279 DK, 01 AUG 2002; 74-609 DK, 01 SEP 2002; 74-395 DK, 01 SEP 2002; 75-220 DK, 01 OCT 2002; 76-402 DK, 01 NOV 2002. RECALLING FIRM/ MANFACTURER Abbott Laboratories Rocky Mount, NC, by letter dated 11/2/01. REASON Mislabeling; Vial label has the numeric graduations for volume (mL) and dosage (mg) transposed relative to the legend titles. PRODUCT 712,950 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Oxygen, USP, Compressed, in cylinder sizes of E, D, M6, M9, and M12, Rx only Recall # D-036-2. CODE Cylinders filled on 8/10/01, 8/11/01, 8/13/01, and 8/14/01. Lot numbers are: 2-H-10-V-1 - Size E, D, and M6; 2-H-10-V-2 - Size E and M6; 2-H-10-V-3 - Size E, D, and M6; 2-H-10-V-4 - Size M6; 2-H-11-V-1 - Size E; 2-H-13-V-1 - Size E; 2-H-13-V-2 - Size E and D; 2-H-13-V-4 - Size E, D, M12, M9, and M6; 2-H-14-V-1 - Size E. RECALLING FIRM/ MANFACTURER Island Supply Welding Co. Norfolk, NE, by phone on 10/18/01. REASON CGMP Deviations, including but not limited to improper cleaning, and filling of high pressure cylinders and calibration of assay equipment. PRODUCT Size E - 100 or 101 (firm is checking to determine the discrepancy); Size D - 26; Size M12 - 2; Size M9 - 1; Size M6 - 59. DISTRIBUTION NE. _______________________ PRODUCT Product: CVP Antacid Anti-Gas Liquid with Simethicone, 12 Fl. Oz., Recall # D-037-2. Distributed by Consumer Value Products, Inc. Temple, TX 76503. CODE Lot 003018. RECALLING FIRM/ MANFACTURER Recalling Firm: Chemrich Holdings, Inc., Los Angeles, CA by mail July 5 and 10, 2001. Manufacturer: York Pharmaceuticals, Inc. Kansas City, KS. REASON Batch failure for Total Aerobic Microbial Count specification (at manufacturer.) PRODUCT 5,352. DISTRIBUTION TX and CO.RECALLS AND FIELD CORRECTIONS: DRUGS CLASS III
_______________________ PRODUCT Estratest Tablets (Esterified Estrogen 1.25mg and Methyltestosterone 2.5mg), Bottles of 100, NDC # 0032-1026-01, Rx only, Recall # D-034-2. CODE Lot 91666, exp. November 2002. RECALLING FIRM/ MANFACTURER Recalling Firm: Solvay Pharmaceuticals, Inc. Marietta, GA. Manufacturer: Solvay Pharmaceuticals, Inc. Baudette, MN. REASON Mis-Labeling -bottles may contain Estratest HS tablets (half strength of both active ingredients). PRODUCT 17,315 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Allegra (fexofenadine hydrochloride) Tablets, 60-mg., 100-ct. bottles packaged in 24-bottle shipping containers, RX, NDC 0088-1107-47, Recall # D-038-2. The responsible firm on the label is Aventis Pharmaceuticals Inc., Kansas City, MO. CODE 1038818, Exp. Dec. 27, 2003; 1039714, Exp. Feb. 6, 2004; 1039715, Exp. Feb. 6, 2004. RECALLING FIRM/ MANFACTURER Aventis Pharmaceuticals, Inc. Kansas City, MO , by letter on 9/27/01. Firm initiated recall is ongoing. REASON Mis-labeling - Shipping carton bears incorrect NDC Bar Code. PRODUCT 30,681/100-ct. bottles (1,278 shipping cartons). DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS II
_______________________ PRODUCT Automated Blood Bank Analyzer, Recall # B-0061-2. CODE ABS2000. RECALLING FIRM/ MANFACTURER Immucor, Inc., Norcross, Georgia, by letters sent on 7/7/00 and 7/10/00. Firm initiated recall is ongoing. REASON Incorrect test results for ABO or Rh led to incorrect interpretation for patient specimens, and could have resulted in the issuance of an incompatible unit of blood. PRODUCT 83 units. DISTRIBUTION Nationwide and Canada, Germany, Hong Kong, Italy, Japan, Netherlands, Philippines, Portugal, Spain and Taiwan. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0091-2; b) Platelets, Recall # B-0092-2. CODE a) Units 13FS73291, 13FS70715; b) Units 13FS73291, 13FS70715. RECALLING FIRM/ MANFACTURER American Red Cross Blood Services, Detroit, MI, by letter dated December 22, 1999. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. PRODUCT 4 units. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0093-2; b) Red Blood Cells, Leukoreduced, Recall # B-0094-2. CODE a) 21KR12623; b) 21KH47459. RECALLING FIRM/ MANFACTURER American Red Cross, Portland, OR, by letter dated February 14, 2001 or March 1, 2001. Firm initiated recall is complete. REASON Blood products, collected from donors who reported travel to an area designated as endemic for malaria, were distributed. PRODUCT 2 units. DISTRIBUTION DC and CA. _______________________ PRODUCT Counterfeit Neupogen (Filgrastim), Recall B-0129-2. CODE 10/1.0 ml. single use vials per carton, Lot Number P000890, Expiration Date 12/02. RECALLING FIRM Grapevine Trading Company, Springboro, OH, by letter dated June 11, 2001. Firm initiated recall is ongoing. REASON Counterfeit Neupogen was distributed. PRODUCT 30 vials. DISTRIBUTION NY. _______________________ PRODUCT a) Red Blood Cells, B-0148-2; b) Platelets, Pheresis, B-0149-2; c) Cryoprecipitated AHF, B-0150-2; d) Fresh Frozen Plasma, B-0151-2; e) Platelets Units, B-0152-2. CODE a) Units 6356321, 6439274, 6605731; b) Units 8279884, 8331857, 8361895, 6691551; c) Unit 6356321; d) Units 6439274, 6605731; e) Units 6356321, 8501617 (split unit), 6439274, 6605731, 8425030 (split unit). RECALLING FIRM/ MANFACTURER Community Blood Centers of South Florida, Inc. Lauderhill, FL, by letters dated June 6, 1997. Firm initiated recall is ongoing. REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus, but were collected from a donor who previously tested repeatedly reactive for the HIV antibody, were distributed. PRODUCT 17 units. DISTRIBUTION FL, NC, NY, IL. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall #B-0165-2; b) Platelets, Recall # B-0166-2; c) Fresh Frozen Plasma, Recall # B-0167-2. CODE a) Unit 13GL03314; b) Unit 13GL03314; c) Unit 13GL03314. RECALLING FIRM/ MANFACTURER American Red Cross Blood Services, Detroit, MI, by letter dated August 8, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed. PRODUCT 3 units. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0168-2; b) Platelets, Recall # B-0169-2. CODE a) Unit 13FM64909; b) Unit 13FM64909. RECALLING FIRM/ MANFACTURER American Red Cross Blood Services, Detroit, MI, by letter dated June 4, 2001. REASON Blood products, collected from a donor who reported having lived in an area designated as endemic for malaria, were distributed. PRODUCT 2 units. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0170-2; b) Red Blood Cells, Leukoreduced, Recall # B-0171-2. CODE a) Unit 13LS50510; b) Unit 13LS49830. RECALLING FIRM/ MANFACTURER American Red Cross Blood Services, Detroit, MI, by letter dated July 20, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported having lived in an area designated as endemic for malaria, were distributed. PRODUCT 2 units. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0177-2; b) Red Blood Cells, Leukoreduced, Recall # B-0178-2; c) Recovered Plasma, Recall # B-0179-2. CODE a) Unit 10612-3125; b) Unit 10622-3951; c) Units 10612-3125, 10622-3951. RECALLING FIRM/ MANFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated October 5, 2000. Manufacturer: United Blood Services, Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of Hepatitis A, were distributed. PRODUCT 4 units. DISTRIBUTION AZ and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0183-2; b) Fresh Frozen Plasma, Recall # B-0184-2. CODE a) Unit L54929; b) Unit L54929. RECALLING FIRM/ MANFACTURER Virginia Blood Services, Richmond, VA, by telephone on March 21, 2001, and by letter dated April 11, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor, were distributed. PRODUCT 2 units. DISTRIBUTION VA. _______________________ PRODUCT a) Capture-R Ready-Screen (Pooled Cells) Test Wells, Lot CW021 and N42, expiration 16 Mar 01; packaged as part of test kit lots 07613, 07614, 05559 or 05561. b) Capture-R Ready-Screen (I and II), Lots X2701, X2801, expiration date 16 Mar 01; lot X29,expiration 30 Mar 01; packaged as part of test kit lots 05567, 05568, 07607, 07608, 09661 or 09662. c) Capture-R Ready-Screen (4), Lot G0101, expiration 16 Mar 01; lot G02 expiration 30 Mar 01; Lot G03, expiration 13 Apr 01; packaged as a stand alone or part of test kit lots, 09672, 09673, 09674, 09675, 11732, 11733, 11734 or 11735. d) Capture-R Ready-ID, Lot ID48, expiration 16 Mar 01; Lot ID49, expiration 30 Mar 01; packaged as part of test kits lots 0558 , 07616, 07622 or 09671. Recall # B-0190-2 CODE a) Lot CW021 and N42, expiration 16 Mar 01; packaged as part of test kit lots 07613, 07614, 05559 or 05561. b) Lots X2701, X2801, expiration date 16 Mar 01; lot X29,expiration 30 Mar 01; packaged as part of test kit lots 05567, 05568, 07607, 07608, 09661 or 09662. c) Lot G0101, expiration 16 Mar 01; lot G02 expiration 30 Mar 01; Lot G03, expiration 13 Apr 01; packaged as a stand alone or part of test kit lots, 09672, 09673, 09674, 09675, 11732, 11733, 11734 or 11735. d) Lot ID48, expiration 16 Mar 01; Lot ID49, expiration 30 Mar 01; packaged as part of test kits lots 0558 , 07616, 07622 or 09671. RECALLING FIRM/ MANFACTURER Immucor, Norcross, GA, by letter dated March 28, 2001. Firm initiated recall is complete. REASON Use of the products may result in the failure to detect some examples of Anti-Fya . PRODUCT 7,226 units DISTRIBUTION Nationwide and in Australia, Belgium, Canada, Denmark, England, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, Philippines, Portugal, Spain, Sweden, and Taiwan. _______________________ PRODUCT Platelets, Recall # B-0206-2. CODE Units 07FF91308, 07FF91318, 07FF94474, 07FF82968, 07FF88679, 07FF84052, 07FF84050, 07FF87930, 07FF88249, 07FE02475, 07FF89971. RECALLING FIRM/ MANFACTURER American National Red Cross, Tucson, AZ, by letters on April 24, 2001, April 9, 2001, April 27, 2001, May 9, 2001, or May 14, 2001. Recall also conducted by telephone on April 9, 2001. Firm initiated recall is complete. REASON Platelets, which were prepared from whole blood units collected from donors who had taken aspirin within thirty-six hours of donation, were distributed. PRODUCT 11 units. DISTRIBUTION AZ, CA, and OK. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0210-2; b) Platelets, Recall # B-0211-2; c) Plasma Unit, Recall # B-0212-2; d) Fresh Frozen Plasma, Recall # B-0213-2. CODE a) Units 03GS47981, 03GV21077; b) Unit 03GV21077; c) Unit 03GS47981; d) Unit 03GS47981. RECALLING FIRM/ MANFACTURER American Red Cross Blood Services, Atlanta, GA, by letter dated December 12, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who had sexual contact with an individual who had lived in an HIV Group O risk area, were distributed. PRODUCT 5 units. DISTRIBUTION GA and CA. _______________________ PRODUCT Platelets, Irradiated, Recall # B-0214-2. CODE Unit 03LM95493 RECALLING FIRM/ MANFACTURER American Red Cross Blood Services, Atlanta, GA, by letter dated July 18, 2001. Firm initiated recall is complete. REASON Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed. PRODUCT 1 unit. DISTRIBUTION GA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0215-2; b) Recovered Plasma, Recall # B-0216-2. CODE a) Unit R35403; b) Unit R35403. RECALLING FIRM/ MANFACTURER San Diego Blood Bank, San Diego, CA, by letter dated February 23, 2001, or by facsimile on or about that date. Firm initiated recall is complete. REASON Blood products, collected from a donor who took the drug Proscar, were distributed. PRODUCT 2 units. DISTRIBUTION CA and VA. _______________________ PRODUCT Pulmonary Artery, Recall # B-0232-2. CODE Serial Number 6105688. RECALLING FIRM/ MANFACTURER CryoLife, Inc., Kennesaw, GA, by letter dated July 9, 2001. Firm initiated recall is complete. REASON Tissue for transplant was collected from a donor who had not been properly evaluated. PRODUCT 1 units. DISTRIBUTION CA. _______________________ PRODUCT Pulmonary Hemi-Artery, Recall # B-0233-2. CODE Serial Numbers 3988325, 3988333. RECALLING FIRM/ MANFACTURER CryoLife, Inc., Kennesaw, GA, by letters dated July 9, 2001. Firm initiated recall is ongoing. REASON Tissue for transplant which was collected from a donor who had not been properly evaluated. PRODUCT 2 unit. DISTRIBUTION CA and NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0256-2. CODE Unit C41140. RECALLING FIRM/ MANFACTURER South Bend Medical Foundation, Inc., South Bend, IN, by telephone on July 30, 2001. 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. PRODUCT 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Recovered Plasma, Recall # B-0257-2. CODE Unit 3036738. RECALLING FIRM/ MANFACTURER Central Florida Blood Bank, Inc., Orlando, FL, by telephone and facsimile on November 13, 2000. Firm initiated recall is complete. REASON Blood product, untested for viral markers, was distributed. PRODUCT 1 unit. DISTRIBUTION FL. _______________________ PRODUCT Red Blood Cells, Recall # B-0258-2. CODE Unit 1906438. RECALLING FIRM/ MANFACTURER Central Florida Blood Bank, Inc., Orlando, FL by telephone on January 10, 2001. Firm initiated recall is complete. REASON Blood product, that tested repeatedly reactive for the antibody to hepatitis B core antigen (anti-HBc), was distributed. PRODUCT 1 unit. DISTRIBUTION FL. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced , Recall # B-0281-2; b) Platelets, Recall # B-282-2; c) Recovered Plasma, Recall # B-283-2. CODE a) Unit 01KX48736; b) Unit 01KX48736; c) Unit 01KX48736. RECALLING FIRM/ MANFACTURER American Red Cross Blood Services, West Henrietta, NY, by telephone on January 16 and 17, 2001, and by letter dated January 23, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor, were distributed. PRODUCT 3 units. DISTRIBUTION NY.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS III
_______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0096-2. CODE Units 3035579, 4052218, 8605491. RECALLING FIRM/ MANFACTURER Community Blood Center, Inc., Appleton, WI, by telephone on July 21, 2000, and by letter dated July 25, 2000. Firm initiated recall is complete. REASON Red Blood Cells, leukoreduced by filtration greater than five days past the time of collection, were distributed. PRODUCT 3 units. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells, Leukoreduced , Recall # B-0097-2. CODE Units 8052552, 8052554. RECALLING FIRM/ MANFACTURER Community Blood Center, Inc., Appleton, WI, by telephone on December 7, 2000, and by letter dated February 28, 2001. Firm initiated recall is complete. REASON Red Blood Cells, leukoreduced by filtration greater than five days past the time of collection, were distributed. PRODUCT 2 units. DISTRIBUTION MI. _______________________ PRODUCT Source Plasma, Recall # B-0147-2. CODE Units (103 units) 0510144339, 0510145354, 0510145384, 0510145390, 0510145392, 0510145396, 0510145467, 0510145489, 0510145505, 0510145506, 0510145514, 0510145530, 0510145551, 0510145586, 0510145587, 0510143731, 0510143903, 0510144354, 0510144546, 0510145219, 0510145274, 0510145307, 0510145377, 0510145391, 0510145426, 0510145439, 0510145445, 0510145453, 0510145455, 0510145458, 0510145498, 0510145591, 0510145592, 0510145595, 0510145596, 0510145597, 0510145598, 0510145599, 0510145600, 0510144688, 0510144689, 0510144724, 0510144730, 0510144737, 0510144741, 0510144742, 0510144782, 0510144784, 0510144787, 0510144910, 0510144983, 0510145006, 0510145041, 0510145043, 0510145454, 0510145475, 0510145478, 0510145520, 0510145558, 0510145567, 0510145568, 0510145583, 0510145593, 0510142816, 0510142853, 0510143200, 0510143501, 0510143722, 0510143968, 0510143988, 0510144212, 0510144355, 0510138923, 0510139630, 0510141105, 0510142993, 0510143558, 0510143582, 0510143619, 0510143632, 0510143704, 0510143728, 0510144076, 0510144108, 0510144124, 0510144138, 0510144622, 0510144739, 0510144883, 0510144893, 0510144905, 0510144988, 0510145252, 0510145305, 0510145509, 0510145512, 0510143949, 0510144054, 0510144455, 0510141666, 0510140258, 0510140388, 0510145253. RECALLING FIRM/ MANFACTURER Recalling Firm: Nabi, Boca Raton, FL, by letter dated April 16, 1998. Manufacturer: Nabi Biomedical Center, Nashville, TN. Firm initiated recall is complete. REASON Blood products, which were stored at unacceptable temperatures, were distributed. PRODUCT 103 units. DISTRIBUTION NY and NC. _______________________ PRODUCT Collagenase Santyl Ointment, Recall # B-0172-2. CODE 15 grams and 30 grams, Lots (3 lots) 0000074200, 0000074201, 0000071342. RECALLING FIRM/ MANFACTURER Advance Biofactures Corporation, Lynbrook, NY, by letter on October 3, 2001. Firm initiated recall is complete. REASON Products, that were found to have exceeded the potency specification, were distributed. PRODUCT 3 lots (43,416 tubes). DISTRIBUTION FL. _______________________ PRODUCT Engerix-B, Hepatitis B Vaccine, Recall # B-0181-2. CODE 20 mcg/ml, Lot ENG33824A. RECALLING FIRM/ MANFACTURER Recalling Firm: Warehouse Distributor, Bindley Western Drug Company, Westbrook, ME, by letter on February 22, 2001. Manufacturer: Glaxo SmithKline Beecham, Rixensart, Belgium. Firm initiated recall is complete. REASON Vaccines that were stored under unacceptable temperatures were distributed. PRODUCT 970 units. DISTRIBUTION ME, NY, VT, MA, RI, NY. _______________________ PRODUCT Ortho Summit Processor, Model # 135028, Recall # B-0201-2. CODE All serial numbers. RECALLING FIRM/ MANFACTURER Ortho Clinical Diagnostics, Raritan, NJ, by letter dated April 17, 2001. Firm initiated recall is complete. REASON The instrument failed to notify users of double row washing and/or lack of row washing of microwell plates, and failed to display an error message for an invalid test. PRODUCT 114 instruments. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS I
_______________________ PRODUCT Melt-spun Cellulose Diacetate Hemodialyzers; a single use sterile device for hemodialysis of patients with acute or chronic renal failure; 12 units per case; A-Series Dialyzers made from Altra Nova Fibers, AF-Series Dialyzers made from Altra Flux Fiber and AX-Series Dialyzers made from Altrex Fiber; a) Recall # Z-0257-2; b) Recall # Z-0258-2; c) Recall # Z-0259-2; d) Recall # Z-0260-2; e) Recall # Z-0261-2; f) Recall # Z-0262-2; g) Recall # Z-0263-2; h) Recall # Z-0264-2; i) Recall # Z-0265-2. CODE a) A-11 Dialyzer, product code 237011, 237511, 237311; b) A-15 Dialyzer, product code 237015, 237515, 237315; c) A-18 Dialyzer, product code 237018, 237518, 237318; d) A-22 Dialyzer, product code 237022; e) AF-150 Dialyzer, product code 238015, 238515; f) AF-180 Dialyzer, product code 238018, 238518; g) AF-220 Dialyzer, product code 238022, 238522; h) AX-15 Dialyzer, product code 239015; i) AX-22 Dialyzer, product code 239022, 239522. All lots of the A-Series Dialyzers, AF-Series Dialyzers and AX- Series DialyzersBaxter also recalled the following lots of cellulose acetate fibers as a precautionary measure: catalog numbers 100-416, 100- 923, 700-098, 700-150. 1) Altra Nova, lots 990924P1D1 thru 011019P4A; 2) Altra Flux, lots 990904P6A1 thru 011017P7A; 3) Altrex, lots 990929P6A1 thru 000203P6A1. RECALLING FIRM/ MANFACTURER Recalling Firm: Baxter Healthcare Corp. Round Lake, IL, by telephone on 10/18/01 and recall letters dated 10/18/01. Manufacturer: Baxter/Althin Medical AB Ronneby, SW. Firm initiated recall is ongoing. REASON Hemodialyzers associated with deaths in Croatia and Spain. PRODUCT 2,435,306 dialyzers. DISTRIBUTION Nationwide and international. The AX-series dialyzers were not distributed in the United States.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS II
_______________________ PRODUCT The FREEHAND System, a hand grasp implanted functional electrical stimulator, Recall # Z-0267-2 to Recall # Z-0268-2. CODE All serial numbers. RECALLING FIRM/ MANFACTURER Neurocontrol Corp., Valleyview, OH, by telephone on 5/3 and 5/4/2001. Firm initiated recall is ongoing. REASON If the electrode is implanted too deeply, the device will not operate properly. PRODUCT Nationwide and International. DISTRIBUTION 78. _______________________ PRODUCT WatchChild Obstetrical Data Management System, Recall # Z-0269-2. CODE None (No catalog or serial numbers)- Recall affects all WatchChild Systems in the field. RECALLING FIRM/ MANFACTURER Hill-Rom/Netlinx Cary, NC, by letter on 5/1/00. Firm initiated recall is ongoing. REASON Problem with data from fetal and maternal monitors. PRODUCT 335 units. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Inovision/Victoreen NERO mAx, Model 8000, radiologic quality assurance instrument, Recall # Z-0271-2. CODE Serial Numbers: 00107, 000113, 000123, 000132, 000134, 000135, 000142, 000145, 000149, 000156, 000161, 000167, 000168, 000178, 000179, 000180, 000192, 000202, 000213, 000216, 000227, 000234, 000235, 000254, 000259, 000262, 000264, 000268, 000272, 000280, 000287, 000289, 000294, 000296, 000316, 000317, 000323, 000326, 000330, 000335, 000338, 000354, 000362, 000379, 000385, 000390, 000392, 000393, 000394, 000399, 000402, 000420, 089847, 089855, 089860, 089863, 089869, 093754, 093755, 093771, 093773, 095421, 095426, 095431, 095442, 096432, 096433, 096434, 096442, 096444, 097913, 097914, 097920, 097921, 097922, 097923, 097924, 097925, 101889, 101890, 101891, 101892, 101893, 101894, 101895, 101896, 101897, 101898, 102193, 102194, 102195, 102196, 102197, 102198, 102199, 102200, 102201, 102202, 102244, 102445, 102446, 102447, 102448, 102449, 102450, 102451, 102452, 102453, 103036, 103037, 103038, 103039, 103040, 103041, 103042, 103043, 103044, 103045, 103521, 103522, 103523, 103524, 103525, 103526, 103527, 103528, 103529. RECALLING FIRM/ MANFACTURER Inovision Radiation Measurements, Solon, OH, by letter on 7/27/2001. Firm initiated recall is ongoing. REASON Due to improper calibration, the units will read 10X higher than actual. PRODUCT Nationwide and international. DISTRIBUTION 127 units. _______________________ PRODUCT CircuVent, Recall # Z-0272-2. CODE Part Number 68-1000 Packed 10 units per case. Responsible firm on label: DHD Healthcare, Wampsville, NY. Codes: 120503, 121306, 122710. RECALLING FIRM/ MANFACTURER DHD Healthcare Corp., Wampsville, NY, by telephone on 8/22/01, followed by faxed letter on 8/23/01. Firm initiated recall is ongoing. REASON Indicator labels in wrong orientation. PRODUCT 273 cases (10 per case). DISTRIBUTION Nationwide. _______________________ PRODUCT Steris brand S2000 Sterilant, packaged in cases containing 20 boxes of Steris 20 Sterilant Concentrate, each box containing 2 bottles, 160.7 gm dry powder component in one bottle and 2.02 fl ounce liquid component in the other, Recall # Z-0273-2. CODE Item # S2000, Lot #A48301121, labeled as exp. June 2002. RECALLING FIRM/ MANFACTURER MDR Specialty Distribution Corporation Williamsburg, VA, by letter 9/18/2001. Firm initiated recall is ongoing. REASON Distributor relabeled sterilant with extended expiration date. PRODUCT 100 cases/20 bottles per case. DISTRIBUTION Distribution centers in NC, VA, TN, and IL. _______________________ PRODUCT Radionics XKnife RT Software, Recall # Z-0275-2. CODE Version 1.02 and lower. RECALLING FIRM/ MANFACTURER Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephone between 9/17/2001 and 18/01. Firm initiated recall is ongoing. REASON Software error may cause incorrect jaw settings for a record/verify system. PRODUCT 51. DISTRIBUTION Nationwide and International. _______________________ PRODUCT Sterile 3.5mm x 25.0mm Cortical Screw, lot #W02675. This implant belongs to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. This device is single use and provided sterile as stated on the labeling, Recall #Z-0277-2. CODE Lot #W02675. RECALLING FIRM/ MANFACTURER Acumed, Inc. Beaverton, OR, faxed or e-mailed on 10/5/01 to distributors a recall notice marked "Urgent" that requested return of the product. Firm initiated recall is ongoing. REASON Extended sterilization expiration date. PRODUCT 91. DISTRIBUTION CA, UT, GA, KS, MO and Sweden, Denmark, United Kingdom, Korea, Japan, and Australia. _______________________ PRODUCT Model 93 Series, Squadmate Ambulance Cots , Recall # Z-0283-2/Z-0288-2. CODE Cot Models: 93-ES, 93-EX, 93-ESST, 93-EXST, 93-IT, 93-ITA having serials number between L-611423 and L-639553, were subject to correction. RECALLING FIRM/ MANFACTURER Ferno-Washington, Inc. Wilmington, OH, by letters mailed on 9/14/2001. REASON The locking mechanism may fail and cause injury to the patient or operator. PRODUCT 658 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Stryker Endoscopy brand disposable Arthroscopic Bur with 4.0mm Barrel Bur Model #s/Part#s: a) 275-941-000, 6 Flute, Hooded Barrel Bur, Recall # Z-0291-2; b) 275-941-012, 12 Flute, Hooded Barrel Bur, Recall # Z-0292-2; c) 275-941-200, 6 Flute, Unhooded Barrel Bur, Recall # Z-0293-2. CODE a) Part #: 275-941-000, 4.0mm 6 Flute Barrel Bur Lot #s: 01085692; 01085772; 01065512; 01065552; 01065572; 01075612; 01075652. b) Part #: 275-941-012, 4.0mm 12 Flute Barrel Bur Lot #s: 01085752; 01085772; 01055492; 01065512; 01075592. c) Part No. 275-941-200, 4.0mm 6 Flute Unhooded Barrel Bur Lot#s: 01085732; 01085752. RECALLING FIRM/ MANFACTURER Stryker Endoscopy, Santa Clara, CA, by voice mail on 9/28/01 followed by written notification on 10/1/01. Firm initiated recall is ongoing. REASON The bur head can separate from the shaft during use. PRODUCT 6,400 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Vacutainer Sodium Polyanethol Sulfonate (SPS) Blood Culture Specimen Collection Tube, Catalog #366404, Recall # Z-0294-2. CODE Catalog No. 366404, Lot 0339536, 1037417, and 1127925. RECALLING FIRM/ MANFACTURER Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ by letter on 10/18/2001. Manufacturer: Becton Dickinson & Co., Broken Bow, NE. Firm initiated recall is ongoing. REASON When stopper is pulled out, healthcare worker may contact collected blood specimen. PRODUCT Lot 0339536--approx. 240,000; Lot 1037417 --approx..243,000; Lot 1127925 -- approx. 193,000. DISTRIBUTION Nationwide and Canada.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS III
_______________________ PRODUCT Deproteinizer Solution B, Recall # Z-0270-2. CODE Lot R1D123, Exp. 3/03. RECALLING FIRM/ MANFACTURER Recalling Firm: Diamond Diagnostics Inc., Holliston, MA. Manufacturer: Ameresco Solon, OH. Firm initiated recall is ongoing. REASON Product may be contaminated with salmonella. PRODUCT 48 vials. DISTRIBUTION Malayasia and Indonesia. _______________________ PRODUCT Kodak 100-film autoloader for the Kodak LS40, LS50, LS75, and LS85 Film Digitizers and Lumisys Autoloader Film Autoloader, Recall # Z-0274-2. CODE Cat. # 0072-745: S/Ns 39667, 40020, 13926; Cat. # 808224: S/N A0002. RECALLING FIRM/ MANFACTURER Eastman Kodak Co., Rochester, NY, by telephone on 8/17/01 and by visits between 8/23/2001 through 9/4/01. Firm initiated recall is ongoing. REASON Potential shock hazard. PRODUCT 4 units. DISTRIBUTION CO, TX, and WV.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE CLASS III
_______________________ PRODUCT Southwest Choice Premium Senior Horse Feed which is a non-medicated pelleted horse feed. The feed is packaged in 50 pound sacks which are labeled in part: "***Senior***Premium***Horse***Feed*** Recall # V-005-2. CODE All bags of feed that were date coded with "6-13-01" between June 13, 2001 through and including June 15, 2001. RECALLING FIRM/ MANFACTURER Eagle Milling Company, Inc., Casa Grande, Arizona, by telephone on August 31, 2001. Firm initiated recall is ongoing. REASON The animal feed is adulterated because it contains a type A medicated veterinary drug article Rumensin (monensin) which, if ingested, is fatal to horses. PRODUCT 960 fifty lbs bags. DISTRIBUTION AZ. _______________________ PRODUCT Sacox 60 (Salinomycin Sodium) Type A Medicated Article. The product is for the prevention of coccidiosis in broiler chickens, Recall # V-006-2. CODE Lot numbers M1058060, M1057058, M1057059, M1064063, Q10600691, Q1073075, Q1060062, and Q1075076. The "M" lots are manufactured by Merial, St. Louis, Missouri, and the "Q" lots are manufactured by Alpharma, Lowell, Arkansas. RECALLING FIRM/MANFACUTRER Intervet, Inc., Millsboro, Delaware, by telephone on August 1, 2001. REASON Subpotent. PRODUCT A total of 1,920 fifty pounds bags. DISTRIBUTION AL, AR, KY and MD.
END OF ENFORCEMENT REPORT FOR NOVEMBER 21, 2001
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