May 8, 2002 02-18
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT RED BARN Orange Pineapple Yogurt Cake Mix Net Wt. 16 oz. Recall # F-385-2. CODE The product is not coded. RECALLING FIRM/MANUFACTURER Fairfield Farm, Rochester, NY, by telephone on October 26, 2001, by letters on October 27 and November 1, 2001 and by press release issued on October 26, 2001. State initiated recall is complete. REASON Undeclared Sulfites. VOLUME OF PRODUCT IN COMMERCE 159 units. DISTRIBUTION NY. _______________________ PRODUCT Imported sundried tomatoes in pure olive oil packaged in glass jars under the following labels: a) COSMO'S, 8 FL.OZ. b) CIRO, 8 FL. OZ c) FAMOSO, 8 FL. OZ. d) DAL RACCOLTO, 7 FL. OZ Recall # F-386-2. CODE All lot numbers. RECALLING FIRM/MANUFACTURER Cosmos Food PRODUCTs Inc., West Haven, CT, by telephone on June 6, 2001 and by fax on June 7, 2001. Firm initiated recall is complete. REASON PRODUCT contains undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 1000 cases (12/case). DISTRIBUTION New England States, NY, NJ and D.C.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Isabella's Sugar Free Muffins Toasted Almond, Net Wt. 16 oz.(454g). Recall # F-383-2. CODE Product distributed prior to 3/1/02 with the label that failed to declare almonds in the ingredient statement. RECALLING FIRM/MANUFACTURER Recalling Firm: Isabella's, a division of Feature Foods, Inc., Providence, RI, by recall notification on March 1, 2002. Manufacturer: Main Street Gourmet, Cuyahoga Falls, OH. Firm initiated recall is complete. REASON Product contains undeclared almonds. VOLUME OF PRODUCT IN COMMERCE 78 cases (12/4 pk/case). DISTRIBUTION CT, MA, NY, NJ, and RI. _______________________ PRODUCT Criollo brand Queso Blanco White Cheese with a net weight of approximately 0.75 lbs. each package. Recall # F-387-2. CODE Expiration date of NOV 15 2001. RECALLING FIRM/MANUFACTURER Cardonic Corp., Miami, FL, by visit on October 8, 2001. FDA initiated recall is complete. REASON FDA sample results revealed contamination with Staphylococcus aureus. VOLUME OF PRODUCT IN COMMERCE 576/.75 lbs. DISTRIBUTION FL.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT Strawberry Gatorade Ice Thirst Quencher in 32 fl. oz. bottles, 12 bottles per case. Recall # F-384-2. CODE Bottle code: O29A211 xx:xx and O29A221 xx:xx, where xx:xx is the military time; Case code: STRA ICE 32525/JAN-29-02 O1 hh:mm xxxxx/12-32 oz. Stores may have received the cases of Strawberry Ice by themselves or in a retail mixed display pallet of 70 cases of 6 flavors, with a total of 7 cases of Strawberry Ice. The mixed display pallet has a pallet placard UPC 32097. RECALLING FIRM/MANUFACTURER Recalling Firm: The Quaker Oats Co., Chicago, IL, by letters on April 8, 2002. Manufacturer: The Quaker Oats Co., Oakland, CA. Firm initiated recall is ongoing. REASON The product was contaminated with mold. VOLUME OF PRODUCT IN COMMERCE 11,047 cases. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Junior Strength Motrin Tablets, Grape Flavored, Chewables (Ibuprofen 100 mg) 24 tablets per bottle. Recall # D-245-2. CODE Lot EBM073 exp. 2/03. RECALLING FIRM/MANUFACTURER McNeil Consumer & Speciality Pharmaceuticals, Fort Washington, PA, by letters on April 1, 2002. Firm initiated recall is ongoing. REASON Tablet mix-up; product may contain one or more Women's Tylenol Menstrual Relief Caplets. VOLUME OF PRODUCT IN COMMERCE 79968 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Hydrochlorothiazide Tablets, USP, 25 mg, 1000-count Bottles. Recall # D-252-2. CODE Lot no. 101607A, Exp. date 10/04. RECALLING FIRM/MANUFACTURER Recalling Firm: Ivax Pharmaceuticals, Inc., Miami, FL, by letters March 21, 2002. Manufacturer: Ivax Pharmaceuticals Caribe, Inc., Cidra, Puerto Rico. Firm initiated recall is ongoing. REASON Tablet mixup with Hydrochlorothiazide 50mg and/or Acyclovir 400 mg tablets. VOLUME OF PRODUCT IN COMMERCE 17,117 bottles. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Cortizone 5 and Cortizone Kids Creme, (hydrocortisone) 0.5%, Anti-Itch Creme, 0.5, 0.65, 1, 1.3 and 2 ounce tubes, over-the-counter. Recall # Dñ242-2. CODE All lots within expiry. RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer Consumer Healthcare, Morris Plains, NJ, by letters on February 6, 2002. Manufacturer: Pfizer Inc., Parsippany, NJ. Firm initiated recall is ongoing. REASON Subpotent for Hydrocortisone ingredient (stability). VOLUME OF PRODUCT IN COMMERCE 2,181,859 tubes DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Triamcinolone Acetonide Lotion, USP, 0.1%, Rx only, 60 mL plastic bottles. Recall # D-246-2. CODE Lot Expiration Date NDC number(s) M 405 4/02 49158-211-32, 0182-1777-68, 0536-2360-61, 0603-7855-49 M 441 5/02 49158-211-32, 0182-1777-68, 0603-7855-49, 0364-7346-58 M 480 6/02 49158-211-32, 0603-7855-49, 0364-7346-58 M 504 7/02 49158-211-32, 0182-1777-68, 0603-7855-49, 0364-7346-58 M 546 8/02 49158-211-32, 0603-7855-49, 0364-7346-58 M 615 10/02 49158-211-32, 0182-1777-68, 0603-7855-49 M 623 12/02 49158-211-32, 0182-1777-68, 0603-7855-49, 0364-7346-58 M 697 1/03 49158-211-32, 0603-7855-49 M 716 2/03 0364-7346-58 M 749 2/03 0182-1777-68, 0603-7855-49 M 812 3/03 49158-211-32, 0182-1777-68, 0364-7346-58 M 846 5/03 49158-211-32, 0182-1777-68, 0603-7855-49, 0364-7346-58 M 911 6/03 49158-211-32, 0364-7346-58 M 931 6/03 0182-1777-68, 0603-7855-49, 0364-7346-58 M 948 7/03 49158-211-32, 0364-7346-58, 0603-7855-49 N 002 8/03 49158-211-32, 0364-7346-58, 0603-7855-49 N 070 10/03 49158-211-32, 0364-7346-58, 0603-7855-49 N 088 11/03 49158-211-32, 0603-7855-49 N 136 12/03 49158-211-32, 0182-1777-68, 0603-7855-49, 0364-7346-58 N 685 4/03 0182-1777-68, 0364-7346-58 N 754 4/03 49158-211-32, 0182-1777-68, 0364-7346-58 N 796 5/03 49158-211-32, 0182-1777-68, 0603-7855-49 N 230 2/04 49158-211-32, 0364-7346-58, 0603-7855-49 N 302 4/04 49158-211-32, 0364-7346-58, 0603-7855-49 N 330 5/04 49158-211-32, 0364-7346-58, 0603-7855-49 N 423 8/04 0364-7346-58 N 424 8/04 49158-211-32, 0182-1777-68, 0603-7855-49 N 480 9/04 0364-7346-58 N 499 12/04 49158-211-32, 0364-7346-58, 0603-7855-49 N 545 11/04 0182-1777-68, 0603-7855-49 N 617 1/05 49158-211-32, 0182-1777-68, 0603-7855-49 N 651 3/05 49158-211-32, 0182-1777-68, 0603-7855-49 N 862 7/05 49158-211-32, 0182-1777-68, 0603-7855-49 N 873 7/05 0591-7346-60 N 874 7/05 0591-7346-60 N 906 8/05 0591-7346-60, 0182-1777-68, 0603-7855-49 N 949 10/05 49158-211-32, 0182-1777-68, 0591-7346-60 P 017 12/05 0591-7346-60 P 018 12/05 49158-211-32, 0182-1777-68, 0603-7855-49, 0591-7346-60 P 026 12/05 49158-211-32, 0603-7855-49 Thames NDC: 49158-211-32 Qualitest NDC: 0603-7855-49 Rugby NDC: 0536-2360-61, Prod. No. 602-2362 Schein NDC: 0364-7346-58 Goldline NDC: 0182-1777-68 Watson NDC: 05917-7346-60 RECALLING FIRM/MANUFACTURER Thames Pharmacal Co., Inc., Ronkonkoma, NY, by fax on March 21, 2002. Firm initiated recall is ongoing. REASON Subpotent (stability). VOLUME OF PRODUCT IN COMMERCE 402,037 x 60 mL bottles total. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT a) Levothyroxine Sodium tablets, USP, 25 mcg. (0.025 mg)100 and 1000 tablet bottles, Rx only, under the Qualitest, Vintage and URL label. Recall # D-247-2; b) Q-Tuss Tablets, Sustained Release, Rx only, 100 and 500 tablet bottles and bulk drums under the Qualitest and Vintage label. Each sustained release tablet contains: Phenylephrine HCl 25 mg Phenylpropanolamine HCl 50 mg Chlorpheniramine Maleate 8 mg Hyoscyamine Sulfate 0.19 mg Atropine Sulfate 0.04 mg Scopolamine Hydrobromide 0.01 mg Recall # D-248-2; c) Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules (5 mg/2.5 mg) Rx only, 1000 tablet bottles under the Qualitest and Vintage label Recall # D-249-2. CODE a) Levothyroxine 0.025 mg. 002129C, 002129D, 002129E b) Q-Tuss Tablets 039029A, 039029B, 039029C, 039029D, 138039B, 138039C, 142079A, 142079B c) CDP/Clidinium Bromide Tablets 034128A, 034128B. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on November 13, 2000. Firm initiated recall is complete. REASON Stability; Potency data does not support labeled expiration date. VOLUME OF PRODUCT IN COMMERCE a) 4,177 bottles Levothyroxine Sodium; b) 21,796 bottles and 495,222 tablets Q-Tuss; c) 2,693 bottles CDP/Clidinium Bromide. DISTRIBUTION AL. _______________________ PRODUCT a) Colchicine Tablets, USP, 0.6 mg, Rx only, 100 and 1000 tablet bottles under the Qualitest label. Recall # D-250-2; b) Phenazopyridine Hydrochloride Tablets, USP, 200 mg, Rx Only, 100 and 1000 tablet bottles under the Qualitest and Vintage label. Recall # D-251-2. CODE a) 055090A, 055090B, 112070A, 113070A; b) 045070A, 045070B, 045070C. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on November 13, 2000. Firm initiated recall is complete. REASON Unapproved deviations in manufacturing process (CGMP's). VOLUME OF PRODUCT IN COMMERCE a) 23,096 bottles; b) 8,599 bottles. DISTRIBUTION AL.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Recall # B-0982-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0983-2; c) Fresh Frozen Plasma, Recall # B-0984-2. CODE a) Unit Numbers: 53FE38703, 53FE38710, 53FE38712, 53GF14940, 53GF14941, 53GF14943, 53GF15017, 53GF15018, 53GF15019, 53GF15020, 53GF15021, 53GF15022, 53GF15023, 53GF15024, 53GF15043, 53GF15044, 53GF15045, 53GF15048, 53GF15049, 53GF15063, 53GF15064, 53GF15065, 53GF15066, 53GF15067, 53GF15068, 53GF15087, 53GF15088, 53GF15089, 53GF15090, 53GF15091, 53GF15092, 53GF15132, 53GF15133, 53GF15134, 53L95008, 53L95009, 53L95010, 53L95011, 53L95012, 53FL61648, 53FL61649, 53FL61650, 53FL61651, 53FL61652, 53FL61654, 53FL61655, 53FL61656, 53FL61657, 53FL61658, 53FL61659, 53FL61660, 53FL61662, 53FL61663, 53FL61664, 53FL61665, 53FL61666, 53FL61667, 53FL61668, 53FL61669, 53FL61670, 53FL61671, 53FK40381, 53FK40384, 53FK40385, 53FP11665, 53FP11666, 53FP11667, 53FP11668, 53FL61814, 53FL61834, 53FL61836, 53FL61837, 53FJ43839, 53FJ43840, 53FJ43841, 53FJ43842, 53FJ43843, 53FJ43844, 53FJ43845, 53FJ43847, 53FJ43848, 53FJ43849, 53FJ43850, 53FJ43852, 53FJ43853, 53FJ43854, 53FJ43855, 53FJ43856, 53FJ43857, 53FJ43858, 53FJ43859, 53FJ43860, 53FJ43861, 53FJ43862, 53FJ43863, 53FJ43864, 53FJ43865, 53FJ43867, 53GV21812, 53FJ43905, 53GR10346, 53GR10347, 53Y67539, 53Y67540, 53Y67576, 53Y67577, 53GV21496, 53GV21497, 53GV21498, 53GV21499, 53GV21500, 53GV21501, 53GV21502, 53GV21503, 53GV21504, 53GV21505, 53GV21506, 53GV21510, 53GV21526, 53GV21527, 53FP11410, 53FM16938, 53FM16939, 53FM16940, 53FM16941, 53M68875, 53M68876, 53M68877, 53M68878, 53M68879, 53M68880, 53FN36829, 53FN36832, 53FJ43517, 53FJ43518, 53FJ43519, 53FJ43520, 53FJ43521, 53FJ43522, 53FJ43531, 53FJ43532, 53FJ43533, 53FJ43534, 53FJ43535, 53FJ43536, 53FJ43537, 53FJ43538, 53FJ43539, 53FJ43541, 53FJ43542, 53FJ43543, 53FJ43544, 53FJ43545, 53FJ43546, 53FJ43553, 53FJ43554, 53FJ43555, 53FJ43602, 53FJ43603, 53FJ43604, 53GQ55535, 53T44878, 53T44879, 53GC08568, 53GL88735, 53GL88740, 53GL88742, 53GL88745, 53GL88746, 53GL88747, 53GC08566, 53GC08569, 53GC08572, 53GC08573, 53GC08574, 53FE37524, 53Z17569, 53Z17570, 53Z17571, 53Z17572, 53Z17573, 53Z17574, 53FL60442, 53FL60443, 53FL60445, 53LL27415, 53LL27416, 53LL27417, 53LL27418, 53LL27419, 53LL27420, 53LL27421, 53LL27425, 53LL27426, 53FJ41836, 53FJ41837, 53FJ41838, 53FJ41839, 53FJ41840, 53FJ41841, 53FJ41842, 53FJ41843, 53FJ41844, 53FJ41857, 53FJ41858, 53FJ41859, 53FJ41860, 53FJ41861, 53FJ41862, 53FJ41863, 53FJ41864, 53FJ41865, 53FJ41866, 53FJ41867, 53FJ41868, 53FJ41869, 53FJ41870, 53FJ41871, 53FJ41872, 53FJ41873, 53FJ41874, 53FJ41875, 53FJ41876; b) Units 53GF14939, 53GF14942, 53Y67541, 53Y67575; c) Units 53GF15022, 53GF15043, 53GF15047, 53GF15063, 53FJ43862, 53GV21498, 53GV21500, 53M68875, 53FJ43532, 53GC08568, 53GL88742, 53GC08569, 53LL27422, 53FJ41842, 53FJ41859, 53FJ43847, 53FN36829. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone, fax and letters between February 24, 1997 and June 5, 1997. Firm initiated recall is complete. REASON Blood products, that were produced from 500 ml units of Whole Blood that were collected in 450 ml bags, were distributed. VOLUME OF PRODUCT IN COMMERCE 237 units. DISTRIBUTION MD, VA, Washington DC, PA, GA and Puerto Rico. _______________________ PRODUCT a) GS National Weed Mix, Recall # B-1081-2. b) Candida/Monilia albicans, Recall # B-1082-2; c) GS Mold Mix, Recall # B-1083-2; d) Box Elder, Recall # B-1084-2. CODE a) Lot P32181A2; b) Lot M15532A6; c) Lot M0337B3A2; d) Lot 82461A6. RECALLING FIRM/MANUFACTURER Greer Laboratories, Inc., Lenoir, NC, by telephone and/or letter on August 17, 2001. Firm initiated recall is complete. REASON Allergenic extracts, which were labeled with an incorrect concentration of 1:20 w/v instead of the correct concentration of 1:10 w/v, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 vials. DISTRIBUTION NJ, NY, TX, VA and Thailand. _______________________ PRODUCT Gamimune? N, 10% (Immune Globulin Intravenous), Recall #B-1085-2. CODE Lots 648X078 and 648X062. RECALLING FIRM/MANUFACTURER Bayer Corp., Clayton, NC, by letters dated February 1, 2002 and March 14, 2002. Firm initiated recall is ongoing. REASON Intravenous drug PRODUCTs, which contained particulate matter, were distributed. VOLUME OF PRODUCT IN COMMERCE 8,961 vials. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1173-2; b) Platelets, Recall # B-1174-2; c) Cryoprecipitated AHF, Recall # B-1175-2; d) Source Leukocytes, Recall # B-1176-2; e) Recovered Plasma, Recall # B-1177-2. CODE a) and b) Unit numbers 3910061 and 3940851; c) Unit number 3940851; d) and e) Unit number 3910061. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on March 27, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a previous donationÃs association with a case of post transfusion hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION TX and NJ. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1178-2; b) Cryoprecipitated AHF, Recall # B-1179-2; c) Recovered Plasma, Recall # B-1180-2. CODE a), b) and c) Unit number 4036819. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on June 21, 2001. Firm initiated recall is complete. 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 3 units. DISTRIBUTION TX and NJ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1181-2; b) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1182-2; c) Platelets, Recall # B-1183-2; d) Cryoprecipitated AHF, Recall # B-1184-2; e) Fresh Frozen Plasma, Recall # B-1185-2; f) Source Leukocytes, Recall # B-1186-2; g) Recovered Plasma, Recall # B-1187-2. CODE a) Unit number 3688363; b) Unit numbers 3891739 and 4078543; c) Unit numbers 3688363 and 3891739; d) Unit number 4078543; e) Unit 3688363 and 3891739; f) Unit number 3688363; g) Unit number 4078543. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on August 29, 2001. Firm initiated recall is complete. 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 10 units. DISTRIBUTION TX, CA and NJ. _______________________ PRODUCT Source Plasma, Recall # B-1199-2. CODE Unit number T-61446-011. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., City of Industry, CA, by letter on May 16, 2001. Firm initiated recall is complete. REASON Source Plasma was not properly quarantined and was distributed after the receipt of information that disqualified the donor of the PRODUCT. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1200-2. CODE Unit numbers G-72002-072, G-70794-072, G-69959-072, G-66335-072, G-64132- 072, G-63667-072, G-62160-072, G-60922-072, G-60210-072, G-59372-072, and G58697-072. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., City of Industry, CA, by fax on February 12, 2001. Firm initiated recall is complete. REASON Source Plasma, that tested negative for hepatitis B, but were collected from a donor that the recalling firm was notified had previously tested positive for hepatitis B by the polymerase chain reaction assay, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION Spain and Sweeden. _______________________ PRODUCT Source Plasma, Recall # B-1203-2. CODE Unit numbers: GN0000435, GN0000441, GG0003350, GG0003476, GG0003526, GG0003674, GG0003745, GG0003866, GG0003932, GG0004038, GG0004141, GG0004174, and GG0004357. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera Care, Inc., American Plasma, Inc., Colorado Springs, CO, by fax on March 13, 2001. Manufacturer: Sera Care, Inc., American Plasma, Inc., Pasadena, TX. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of residing in the United Kingdom for more than 6 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units. DISTRIBUTION Spain. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1206-2. CODE Unit number 06LK46053. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern California Region, Los Angeles, CA, by letter dated July 12, 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. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1207-2. CODE Unit number 07FV01589. RECALLING FIRM/MANUFACTURER The American National Red Cross, Arizona Region, Tucson, AZ, by letter dated December 28, 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. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1208-2. CODE Unit number 36262-4102. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters on December 5, 2001 and March 1, 2002. Manufacturer: Blood Systems, Inc., Ventura, CA. 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 CA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1209-2. CODE Unit numbers GK26054, GK23475, GK25054, and GJ84134. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated August 29, 2001. Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA. Firm initiated recall is complete. REASON Blood products, collected from donors whose health history screening was inadequately performed in that the donors were not questioned about the recent use of aspirin, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1210-2; b) Fresh Frozen Plasma, Recall # B-1211-2. CODE a) Unit numbers 4027280 and 4036581 b) Unit number 4034722 RECALLING FIRM/MANUFACTURER Recalling Firm: Department of the Navy, Bureau of Medicine and Surgery, Navy Blood Program Office, Washington, DC., by letter on or about May 29, 2001. Manufacturer: Naval Medical Center, San Diego, CA. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from unsuitable donors based previous repeatedly reactive testing for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NV, MD and CA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Platelets, Recall # B-1188-2. CODE Unit number 4165088. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on October 12, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor for which documentation of the inspection of the adequacy of the venipuncture site was not available, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1189-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1190-2; c) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1191-2; d) Platelets, Recall # B-1192-2; e) Platelets Irradiated, Recall # B-1193-2; f) Cryoprecipitated AHF, Recall # B-1194-2; g) Plasma, Recall # B-1195-2; h) Fresh Frozen Plasma, Recall # B-1196-2; i) Source Leukocytes, Recall B-1197-2; j) Recovered Plasma, Recall # B-1198-2. CODE a) Unit number 4054997l; b) Unit number numbers 4054961, 4054967, 4054972, 4054973, 4054978, 4054983, 4054999, 4055001, 4055004, 4061730, 4061732, 4061733, 4061736, 4061739, 4061745, 4061748, 4061750, 4064453, 4064455, 4064457, 4064466, 4064468, 4064470, 4064474, 4064475, 4064480, 4064493, 4064495, 4064501, 4054502, 4064505, 4064507, 4064509, 4064511, 3993353, 4051254, 4051258, 4051258, 4051260, 4051260, 4051261, 4051265, 4051275, 4051278, 4051283, 4051292, 4051297, 4051304, 4051308, 4084598, 4084601, 4084603, 4084605, 4084607, 4084608, 4084611, 4084613, 4084616, 4084618, 4032420, 4032427, 4049648, 4051311, 4051316, 4051318, 4084226, 4084240, 4084241, 4084243, 4084246, 4084250, 4063092, 4063095, 4063101, 4063111, 4063118, 4063118, 4063125, 4063160, 4066609, 4066596, 4066613, 4066616, 4066620, 4083955, 4083962, 4083976, 4083977, 4083994, 4083998, 4084207, 4084208, 4084008, 4084011, 4084013, 4084017, 4084024, 4084029, 4027681, 4027683, 4051362, 4051364, 4084114, 4084119, 4084123, 4084128, 4084132, 4084135, 4084143, 4084146, 4084148, 4084151, 4084154, 4084156, 4084158, 4084160, 4084163, 4084175, 4084179, 4125062, 4125068, 4125078, 4125081, 4125083, 4125087, 4125089, 4125089, 4125093, 4125099, 4125100, 4125107, 4125114, 4125115, 4125121, 4125125, 4125129, 4125131, 4125134, 4125139, 4125143, 4125150, 4123563, 4123568, 4090942, 4090974, 4091044, 4030990, 4030990, 4030994, 4030998, 4030998, 4031002, 4031005, 4031005, 4031010, 4068890, 4068896, 4068919, 4068685, 4063995, 4068703, 4068708, 4031000, 4125075, and 4031000; c) Unit numbers 4054986, 4027694, 4068879, and 4068938; d) Unit number numbers 4054961, 4054962, 4054967, 4054972, 4054973, 4054978, 4054983, 4054986, 4054997, 4055001, 4061730, 4061732, 4061733, 4061736, 4061739, 4061745, 4061748, 4061750, 4064453, 4064459, 4064466, 4064468, 4064470, 4064474, 4064493, 4064495, 4064501, 4054502, 4064505, 4064507, 4064509, 4064511, 3993353, 4051254, 4051261, 4051265, 4051275, 4051278, 4051283, 4051297, 4051304, 4051308, 4084598, 4084601, 4084603, 4084605, 4084607, 4084608, 4084611, 4084613, 4084616, 4032420, 4049648, 4051311, 4051316, 4051318, 4084226, 4084237, 4084240, 4084241, 4084246, 4084250, 4063092, 4063095, 4063111, 4066609, 4066596, 4066613, 4066616, 4066620, 4083955, 4083962, 4083976, 4083977, 4083994, 4083998, 4084207, 4084208, 4084008, 4084013, 4084017, 4084029, 4027694, 4051362, 4051364, 4084119, 4084128, 4084175, 4084179, 4125065, 4125068, 4125075, 4125078, 4125081, 4125083, 4123568, 4090942, 4068873, 4068877, 4068879, 4068882, 4068896, 4068898, 4068900, 4068904, 4068908, 4068911, 4068920, 4068925, 4068938, 4062330, 4063992, 4063995, 4068689, 4068699, 4068704, 4068714, and 4068740; e) Unit number numbers 4064455, 4084135, 4068919, and 4062333; f) Unit number numbers 4054961, 4054962, 4054967, 4054972, 4054973, 4054983, 4054997, 4061730, 4061732, 4061736, 4061739, 4061745, 4061748, 4061750, 4064481, 4064493, 3993353, 4084598, 4084608, 4032427, 4063160, 4066596, 4066613, 4084160, 4125100, 4125107, 4125125, 4125134, 4125150, 4064509, and 4084611; g) Unit number numbers 4055004, 4064481, 4064509, 4084243, 4063160, 4066613, 4084160, 4125107, and 4125150; h) Unit number numbers 4064455, 4064457, 4064468, 4064493, 4064495, 4054502, 4064507, 4051275, 4051278, 4051297, 4049648, 4051311, 4051316, 4051318, 4084226, 4084237, 4084241, 4063095, 4063111, 4083976, 4083977, 4083994, 4083998, 4084207, 4084208, 4084011, 4084013, 4084029, 4084119, 4084179, 4125062, and 4125081; i) Unit numbers 4064453, 4064455, 4064457, 4064459, 4064466, 4064468, 4064470, 4064474, 4064480, 4064481, 4064495, 4064501, 4064505, 4064507, 4051254, 4051261, 4051265, 4051275, 4051278, 4051283, 4051297, 4051304, 4051308, 4051311, 4051316, 4051318, 4084226, 4084237, 4084240, 4084241, 4084243, 4084246, 4084250, 4063092, 4063095, 4063101, 4063111, 4063125, 4063160, 4083955, 4083962, 4083976, 4083977, 4083994, 4083998, 4084207, 4084208, 4084008, 4084013, 4084017, 4084029, 4051362, 4051364, 4084114, 4084117, 4084119, 4084123, 4084128, 4084132, 4084135, 4084151, 4123563, 4123568, 4090942, 4062328, 4062330, 4062333, 4068685, 4068689, 4068694, 4068699, 4068703, 4068704, 4068706, 4068708, 4068712, 4068714, 4068736, and 4068740; j) Unit numbers 4054961, 4054962, 4054967, 4054972, 4054973, 4054978, 4054983, 4054986, 4054997, 4055001, 4061730, 4061732, 4061733, 4061736, 4061739, 4061745, 4061748, 4061750, 4064453, 4064459, 4064466, 4064470, 4064475, 4064480, 4064501, 4064505, 3993353, 4051254, 4051261, 4051265, 4051283, 4051292, 4051304, 4051308, 4084608, 4032420, 4032427, 4084240, 4084246, 4063092, 4066596, 4083955, 4083962, 4084024, 4027681, 4027683, 4027694, 4051362, 4084114, 4084117, 4084175, 4125065, 4125087, 4125093, 4125099, 4125100, 4125114, 4125115, 4125121, 4125125, 4125129, 4125131, 4125134, 4125139, 4125143, 4090942, 4091013, 4030994, 4031002, 4031008, 4031010, 4068873, 4068877, 4068879, 4068882, 4068893, 4068896, 4068898, 4068908, 4068919, 4068920, 4068922, 4068925, 4062330, 4062333, and 4063995. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on July 3, 2001. Firm initiated recall is complete. REASON Blood products, collected from donors whose body temperature may have been inadequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 529 units. DISTRIBUTION TX, NY, AK, NJ, IL, MO, CA, OH and MI. _______________________ PRODUCT Source Plasma, Recall # B-1201-2. CODE Unit number I-01091801. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., City of Industry, CA, by fax on September 25, 2001. Firm initiated recall is complete. REASON Source Plasma, incorrectly tested for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________ PRODUCT Source Plasma, Recall # B-1202-2. CODE Unit number GG0009088. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera Care, Inc., American Plasma, Inc., Colorado Springs, CO, by fax on November 2, 2001. Manufacturer: Sera Care, Inc., American Plasma, Inc., Pasadena, TX. Firm initiated recall is complete. REASON Blood product, that tested negative for viral markers, but was collected from a donor whose health history was inadequately determined, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1204-2. CODE Unit numbers FQ03946, LW06011, LW06064, and LW06078. RECALLING FIRM/MANUFACTURER HemaCare Corp., Sherman Oaks, CA, by telephone on November 30, 2001. Firm initiated recall is complete. REASON Blood products, subjected to incorrect storage temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
*****CORRECTIONS*****
In the 02-06, February 13, 2002 Enforcement Report, Recall of Datascope Profile 8 French Intra-Aortic Balloon Catheters, PRODUCT numbers 0684-00-02971-01, 0684-00-0299-01, 0884-00-3441-01, and 0884-00- 3441-02, has been assigned recall numbers Z-0518/0521-02. In the 02-17, May 1, 2002 Enforcement Report, Recall of the Femoral Head Implant from the Foundation Hip System: Labeled in part: "FOUNDATION***HIP SYSTEM ZIRCONIA FEMORAL HEAD***encore orthopedics", Recall numbers Z-0895-2/Z-0899-2 was listed as ongoing, and should be listed as complete. Recall of Invacare Mobilare Concentrators, 5 Liter, serial numbers 94K thru 94L, 95A thru 95L, 96A thru 96L, Recall numbers Z-0198-2/Z-0201-2 was originally listed as complete. It should be listed as ongoing. _______________________ PRODUCT GIBCO *** AIM-V Medium, for ex vivo activation of lymphocytes -with L-glutamine -with streptomycin @50 mcg/mL -with gentamicin sulfate, USP @ 10 mcg/mL -without penicillin G sodium. Recall # Z-0918-2. Label states: "Check for product appearance before use. The performance characteristics of this product have not been officially established. It has not been approved to date for any human or animal in vivo applications except for certain investigational studies. ***" Sold in 1000 ml bottles and in 10L bags CODE 1097192, exp. 3/30/03 1097193, exp. 2/28/03 1101041, exp. 4/30/03 1102964, exp. 5/30/03 1107910, exp. 6/30/03 1112578, exp. 8/30/03 1115447, exp. 9/30/03 1119526, exp. 11/30/03. RECALLING FIRM/MANUFACTURER Invitrogen Corp., Grand Island, NY, by letters dated December 21, 2001. Firm initiated recall is ongoing. REASON Media fill failures. VOLUME OF PRODUCT IN COMMERCE 4,149 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Sterile Ethicon Gut Sutures. Recall # Z-0919-2-0921-2. Brand Label: Chromic Surgical Gut Suture Plain Surgical Gut Suture Plain Fast Absorbing Suture CODE Product Code Lot Number Number G12H RAM158 G122H RAM185 RAM186 G123H QPM297 RAM248 G127H RAM057 G152H QPM141 G172H QPM049 QPM142 U207H RAM154 U246H RAM063 634G RAM008 635H RAM051 RAM097 636G QPM187 RAM053 636H RAM079 687G RAM049 752G QPM107 770G QPM108 RAM027 RAM047 796G RAM182 802H QPM170 810H RAM017 H810H RAM014 811H RAM003 RAM024 RAM086 813H RAM144 H820G RAM007 H821G QPM186 RAM034 H822H RAM037 H823H RAM015 843H RAM061 853H RAM021 N863H RAM016 RAM250 913H QPM169 RAM040 914H QPM060 923H QPM138 RAM002 RAM023 924H RAM080 RAM216 1627G QPM112 QPM154 QPM179 1627H QPM111 RAM073 1635G QPM116 1636G RAM150 1637G RAM093 RAM156 1638G QPM151 RAM030 RAM069 1638H RAM031 1640H RAM028 1642G QPM306 1643G QPM307 1653G QPM134 1654G RAM011 RAM029 1824H RAM219 1828H QPM308 RAM089 1915G QPM135 QPM216 QPM298 RAM025 RAM067 1916G QPM148. RECALLING FIRM/MANUFACTURER Recalling Firm: Ethicon, Inc., Somerville, NJ, by letters on February 10, 2002. Manufacturer: Ethicon, Inc., Juarez, Mexico. Firm initiated recall is complete. REASON Secondary packaging has overwrap seal anomaly. VOLUME OF PRODUCT IN COMMERCE 15,409 dozen. DISTRIBUTION Nationwide. _______________________ PRODUCT a) AxSYM Digoxin II. Recall # Z-0956-2; b) TDx/TDxFLx Digoxin II. Recall # Z-0957-2; c) IMx Digoxin. Recall # Z-0958-2. CODE a) List no. 5B73-20; b) List no. 2213-20; c) List no. 9511-60. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Health PRODUCTs, Inc., Barceloneta, Puerto Rico, by letters dated March 26, 2002. Manufacturer: Abbot Health PRODUCTs, Inc., Diagnostic Plant Barceloneta, Puerto Rico. Firm initiated recall is ongoing. REASON Assay may exhibit negative interference from aldosterone inhibitors. VOLUME OF PRODUCT IN COMMERCE N/A because Device correction is independent of lot numbers. DISTRIBUTION Not applicable (N/A) becuase the Device Correction is independent of lot numbers. _______________________ PRODUCT Medex Three-Way Anesthesia Style Stopcock with 20 inch, 33 inch, and 40 inch Extensions with Male Luer Locks and Male Luer Slips. Recall # Z-0986-2/Z-0990-2. CODE Catalog # Lot # MX252L 31F070145 MX252L 31G170028 MX252L 31H090118 MX252L 31H090134 MX252L 31I210027 MX252S 31F070155 MX252S 31G170033 MX252S 31H090129 MX252S 31H290116 MX252S 31I210034 MX253L 31F070149 MX253L 31F270128 MX253L 31H090116 MX253L 31H090127 MX253L 31H270040 MX253L 31H290099 MX253L 31I210026 MX253L 31I210030 MX253L 31J110109 MX253S 31F070153 MX253S 31G170035 MX253S 31H090120 MX253S 31H270058 MX253S 31H290124 MX253S 31I210023 MX254 31F070150 MX254 31H090115 MX254 31H290134 The recalled units do not have expiration dates. RECALLING FIRM/MANUFACTURER Medex, Inc., Dublin, OH, by telephone and fax beginning December 17, 2001. Firm initiated recall is ongoing. REASON The tubing may separate from the stopcock during patient use. VOLUME OF PRODUCT IN COMMERCE 6,880 cases (344,008 units). DISTRIBUTION Nationwide, Canada and New Zealand. _______________________ PRODUCT Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2. CODE The following serial numbers. 49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R, 49525R, 49527R, 49532R, 49536R, 50927R, 50931R, 50935R, 50973R, 51288R, 51496R, 51533R, 51658R, 51663R, 51666R, 51674R, 51679R, 51684R, 51690R, 51691R, 51692R, 51694R, 51700R, 51705R, 51751R, 51753R, 51754R, 51758R, 51761R, 51763R, 51766R, 51768R, 51769R, 51781R, 51783R, 51892R, 51893R, 51895R, 51896R, 51899R, 51901R, 51903R, 51910R, 51912R, 51913R, 51916R, 51917R, 51918R, 51919R, 51921R, 51922R, 51925R, 51926R, 51931R, 51932R, 51934R, 51935R, 51939R, 51940R, 51941R, 51944R, 51945R, 51949R, 51950R, 51951R, 51957R, 51958R, 51961R, 51962R, 51963R, 51966R, 51967R, 51969R, 51970R, 51974R, 51975R, 51979R, 51980R, 51981R, 51982R, 51983R, 51984R, 51985R, 51988R, 51989R, 51991R, 51993R, 51996R, 51999R, 52001R, 52003R, 52005R, 52007R, 52011R, 52018R, 52020R, 52021R, 52026R, 52030R, 52032R, 52033R, 52040R, 52041R, 52044R, 52049R, 52050R, 52054R, 52055R, 52057R, 52058R, 52062R, 52065R, 52067R, 52069R, 52072R, 52073R, 52075R, 52077R, 52078R, 52081R, 52084R, 52085R, 52089R, 52090R, 52091R, 52093R, 52094R, 52095R, 52098R, 52100R, 52106R, 52108R, 52117R, 52125R, 52127R, 52133R, 52263, 52343R, 52413R, 52620, 52744R, 52771R, 53016, 53047, 53052, 53131, 53146, 53154, 53626, 53813, 53862, 54147, 54458, 54471, 54476, 54570, 54574, 54639, 54643, 54757, 54910, 54929, 55063, 55110, 55115, 55202, 55232, 55267, 55274, 55332R, 55398R, 55414, 55433, 55658, 55738, 55757, 55764, 55786, 55815, 55832, 55835, 56205, 56323, 56442, 56479, 56506, 56511, 56540, 56578, 56722, 56785, 56838, 56872, 56924R, 56927R, 56928R, 56940R, 56968, 57199, 57365, 57800, 58070, 58399, 58447, 58686, 58707, 58745, 59541, 59669, 59774, 59758, 60120, 60296, 60342, 60343, 60344, 60347, 60348, 60350, 60354, 60357, 60366, 60367, 60368, 60421, 60422, 60427, 60429, 60431, 60433, 60435, 60437, 60439, 60442, 60559, 61024, 61395, 61469, 61626, 62026, 62035, 62041, 62042, 62045, 62053, 62054, 62056, 62057, 62058, 62195, 62252, 62259; and 62279 THRU 62418; and 62420, 62421, 62425, 62428, 62429, 62433, 62434, 62435, 62436, 62437, 62440, 62443, 62448, 62449, 62450, 62452, 62453, 62454, 62456, 62457, 62465, 62468, 62469, 62470, 62481, 62485, 62486, 62488, 62492, 62506, 62516, 62519, 62522, 62525, 62528, 62529, 62532, 62533, 62538, 62540, 62542, 62543, 62544, 62545, 62546. RECALLING FIRM/MANUFACTURER Sigma International Medina, NY, by letters between March 21 and 28, 2002. Firm initiated recall is ongoing. REASON Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr. VOLUME OF PRODUCT IN COMMERCE 447 infusion pumps and 604 chips v. 3.50.01. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a ventilator breathing circuit. Recall # Z-0992-2/Z-0994-2. CODE The following Part Numbers/Lot Numbers represent all PRODUCT ever shipped. Part Number: 85750 lot numbers: 2127-01 2127-02 2142-01 2142-02 2142-03 2179-01 2179-02 2225-01 Part Number: 85750A lot numbers: 2147-01 2147-02 Part Number: 58750 lot numbers: 2145-01 2160-01 2188-01. RECALLING FIRM/MANUFACTURER Monaghan Medical Corp., Plattsburgh, NY, by letters dated March 20, 2002. Firm initiated recall is ongoing. REASON Collapsable Holding Chamber inadvertently opening. VOLUME OF PRODUCT IN COMMERCE 957 cases/50 per case. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
****CORRECTION****
In the 02-17 Enforcement Report, Hydroview Brand Intraocular Lens, Posterior Chamber Lenses, various diopters. Model Number H60M, Lot Numbers 5YXP and 6R4B, Recall number Z-0933-2 was listed as ongoing and should be listed as complete. _______________________ PRODUCT Prolactin Calibrators, Prolactin Controls, AxSYM and IMx Prolactin Reagents. Recall # Z-0950-2/Z-0953-2. CODE Prolactin Calibrators List 9C07-1 Lot No. Exp. Date 75255Q100 1/12/02 78013Q100 2/19/02 79026Q100 4/9/02 80697Q100 5/28/02 Prolactin Controls List 9C07-10 Lot No. Exp. Date 77575Q100 3/19/02 78753Q100 4/25/02 80284Q100 4/24/02 81124Q100 5/16/02 AxSYM Prolactin Master Calibrators List 7A62-32 Lot No. Exp. Date 75256Q100 1/12/02 78020Q100 2/21/02 79027Q100 4/9/02 80584Q100 5/26/02 83668Q100 7/12/02 IMx Prolactin List No. 2244-22 Lot No. Exp. Date 78752Q100 5/7/02 80548Q100 9/27/02 84329Q100 11/02/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Health PRODUCTs, Inc., Barceloneta, Puerto Rico, by letter on March 22, 2002. Manufacturer: Abbott Health PRODUCT, Inc., Diagnostic Plant Barceloneta, Puerto Rico. Firm initiated recall is ongoing. REASON The concentration of Prolactin may have decreased by approx. 20%. VOLUME OF PRODUCT IN COMMERCE 14,055 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Inrad brand 2 part CHIBA type needle with accumark sheath, 15 cm., sterile. Recall # Z-0996-2. CODE Catalog # 45018. Lot 6990-9004. RECALLING FIRM/MANUFACTURER Inrad, Inc., Kentwood, MI, by letter on February 16, 2000. Firm initiated recall is terminated. REASON 20 cm needle labeled as 15 cm needle. VOLUME OF PRODUCT IN COMMERCE 100. DISTRIBUTION NM.END OF ENFORCEMENT REPORT FOR May 8, 2002 ####
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2002-MAY-10.