January 23, 2002 02-03
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Mini Vegetable Eggroll 8662, 200 count under the Kabobs Label, Recall # F-187-2; Mini Shirmp & Pork Eggroom 8672, 200 count under the Kabobs Label, Recall # F-188-2; Vegetable Potstocker 361, 100 count under the Kabobs label, Recall # F-189-2; Crab Rangoon 366, 100 count under the Kabobs label, Recall # F-190-2; Dragon Shrimp 3631,100 count under the Kabobs label, Recall # F-191-2; Shrimp Potsticker S-9109, 100 count under the Kabobs label, Recall # F-192-2; Shrimp Wonton 367, 100 count under the Kabobs label, Recall # F-193-2. CODE Julian dates of 01001 through 01211. RECALLING FIRM/MANUFACTURER Kabobs, Inc., Lake City, GA, by letter on Aug. 9, 2001. Firm initiated recall is complete. REASON Frozen appetizers contained undeclared whey protein. VOLUME OF PRODUCT IN COMMERCE 1,888 cases. DISTRIBUTION Nationwide and Canada.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Clonazepam Tablets, USP 1 mg, 500 tablet bottles, Rx only, NDC # 0093-0833-05, TEVA brand label. Recall # D-057-2. CODE Lot 356519 exp. 8/03 RECALLING FIRM/MANUFACTURER Recalling Firm: Teva Pharmaceuticals USA North Wales, PA, by letter on 11/15/01. Manufacturer: Teva Pharmaceuticals Jerusalem, Israel. Firm initiated recall ongoing. REASON Misbranding - tablets debossed with incorrect code (93-832 for 0.5mg) VOLUME OF PRODUCT IN COMMERCE 1904 bottles DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Recall # B-0526-2; b) Red Blood Cells, Leukoreduced, Recall # B-0527-2; c) Platelets,Recall # B-0528-2. CODE a) Units 29FV44321, 29FN32612, 29FG76227, 29FC56149, 29FK28659, 29KH20881; b) Unit 29FJ06387; c) Unit 29KH20881. RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk, VA, by letter dated Feb. 6, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION VA, NC and CT. _______________________ PRODUCT Source Plasma, Recall # B-0564-2. CODE Units T-16479-097, T-16660-097. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA by fax dated Dec. 21, 1999. Manufacturer: Alpha Therapeutic Corporation, San Diego, CA. Firm initiated recall is complete. REASON Blood products, collected from a donor who previously tested reactive for HBsAg, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Spain. _______________________ PRODUCT Plasmapheresis, Recall # B-0565-2. CODE Unit T01736. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center,Grand Rapids, MI, by fax dated March 12, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor taking the drug Lipitor, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0566-2; b) Cryoprecipitated AHF, Recall # B-0567-2; c) Recovered Plasma, Recall # B-0568-2. CODE a), b) and c) Unit G61121 RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by fax dated May 2, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who lived in an HIV group O risk area, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MI and Switzerland. ______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0569-2. CODE Unit 6042191. RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on Sept. 26, 2001. REASON Blood product, which was labeled with an incorrect platelet yield, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0570-2. CODE Unit T91528. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by fax dated April 23, 2001. Firm initiated recall is complete. REASON Blood product, that tested negative for antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor that tested repeatedly reactive for anti-HBc on more than one occasion, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells, Recall # B-0571-2. CODE Unit number G32644. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by letter on May 2, 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 MI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0572-2; b) Platelets, Recall # B-0573-2. CODE a) and b) Unit number 01GC48337. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, West Henrietta, NY, by letters dated June 7 and Aug. 8, 2001. Manufacturer: American Red Cross Blood Services, Syracuse, NY. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY and PA. _______________________ PRODUCT Platelets, Recall # B-0574-2. CODE Unit numbers 3386361, 3386355, and 3386354. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by letter dated June 17, 1998. Firm initiated recall is complete. REASON Blood products, labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX and AK. _____________________ PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma, Recall # B-0578-2. CODE a) and b) Unit 1716065 RECALLING FIRM/MANUFACTURER South Texas Blood & Tissue Center, San Antonio, TX, by fax on Aug. 11, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor taking Methadone for pain, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0579-2; b) Recovered Plasma, Recall # B-0580-2. CODE a) and b) Unit 23140-1242 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on March 28, 2001. Manufacturer: United Blood Services, Billings, MT. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of Non-Hodgkins Lymphoma, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MT and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0586-2; b) Platelets, Recall # B-0587-2. CODE a) Unit 6471202, 6471204; b) Unit 6471204. RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX, by telephone and fax on Dec. 15, 2000. Firm initiated recall is complete. REASON Blood products, collected from donors who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Recall # B-0589-2. CODE Unit 25152-5343. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters Sept. 5 and Nov. 29, 2000. Manufacturer: Blood Systems, Inc., Hot Springs, AR Firm initiated recall is complete. REASON Blood product, prepared from an overweight unit of Whole Blood, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AK. _______________________ PRODUCT Platelets. Recall # B-0602-2. CODE Units 1260419, 1261620, 1261621, 1261672, 2737836, 2737838, 2737839, 2737841, 2738572, 2739664, 2739666, 2739668, 2739671, 2739712, 1260605, 1260607, 1260635, 2738046, 2739353, 2739407, 1261358, 1261437, 2739316, 2739350, 1261936, 2740079, 2740080, 2740081, 1261893, 1261933, 1261941, 1261942, 1260474, 1260478, 1260479, 1260480, 1260420, 1260424, 1260469, 1260470, 1260487, 1260489, 1260493, 1260500, 1260669, 1261031, 1261036, 1261216, 1261221, 1261222, 1261316, 1261326, 1261395, 1261435, 1261560, 1261796, 2737873, 2737874, 2737881, 2737882, 2737884, 2737886, 2737888, 2737890, 2738148, 2738648, 2738651, 2739411, 2739466, 2739545, 2739571, 2739829, 2739868, 2739877, 2740124, 2740180, 1260486, 1260513, 1261115, 1261122, 1261314, 1261318, 1261478, 1261484, 1261489, 1261505, 1261511, 1261512, 1261529, 1261531, 1261546, 1261714, 1261715, 1261717, 1261719, 1261722, 1261746, 1261747, 1261750, 1261751, 1261758, 1261774, 1260767, 1261780, 1261785, 1261787, 1261788, 1261789, 1261808, 1261850, 1261860, 1261865, 1261898, 2737908, 2737913, 2737953, 2737957, 2738375, 2738407, 2738569, 2738798, 2738963, 2738964, 2739467, 2739472, 2739544, 2739546, 2739549, 2739550, 2739554, 2739557, 2739565, 2739580, 2739797, 2739798, 2739799, 2739800, 2739823, 2739825, 2739827, 2739864, 2739869, 2739871, 2739872, 2739873, 2739876, 2739881, 2739885, 2739891, 2739959, 2740044, 2740046, 2740050, 1260563, 1260584, 1260588, 1260632, 1260679, 1261673, 1261708, 1261891, 1261932, 1261938, 1261949, 1261987, 1261989, 1261990, 1261991, 1261992, 1262010, 1262013, 1262048, 1262051, 1262054, 1262056, 1262089, 2737978, 2737982, 2737983, 1260632, 2737984, 2737989, 2737990, 2738082, 2738085, 2738136, 2738140, 2738150, 2739265, 2739267, 2739310, 2739311, 2739314, 2740047, 2740076, 2740078, 2740126, 2740127, 2740133, 27400135, 2740136, 2740137, 2740159, 2740156, 2740157, 2740164, 2740217, 2740249 RECALLING FIRM/MANUFACTURER Houchin Community Blood Bank, Bakersfield, CA, by letter dated Aug. 28, 2000. Firm initiated recall is complete. REASON Platelets, with decreased platelet counts, were distributed. VOLUME OF PRODUCT IN COMMERCE 208 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0603-2. CODE Unit numbers 14047091 and 1408715. RECALLING FIRM/MANUFACTURER Nabi, Denton, TX, by letter dated May 20, 1999. Firm initiated recall is complete. REASON Blood products, that tested negative for the hepatitis C virus(HCV), but were collected from a donor that subsequently tested HCV positive, were not properly quarantined and were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-0604-2. CODE Unit 04N295546. RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL, by telephone on May 6, 1999. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of Non-Hodgkins Lymphoma, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0605-2; b) Recovered Plasma; Recall # B-0606-2. CODE a)and b) Unit M30488 RECALLING FIRM/MANUFACTURER Northern California Community Blood Bank, Eureka, CA, by letter on Aug. 17, 1998. Firm initiated recall is complete. REASON Blood products, collected from a donor who had body piercing within 12 months of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Platelets, Pheresis, Recall # B-0607-2. CODE Unit 6500454. RECALLING FIRM/MANUFACTURER Northern California Community Blood Bank, Eureka, CA, by letter dated April 19, 1999. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-0608-2. CODE Unit 4505958. RECALLING FIRM/MANUFACTURER Northern California Community Blood Bank, Eureka, Ca, by telephone on July 24, 1999. Firm initiated recall is complete. REASON Blood product, collected from a donor who tested CMV antibody positive, was labeled as CMV antibody negative. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0609-2; b) Fresh Frozen Plasma, Recall # B-0610-2; c) Recovered Plasma, Recall # B-0611-2. CODE a) Units 0641174, 0636072; b) Unit 0636072; c) Unit 0641174. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letters dated Jan. 19 and 22, 2001. Manufacturer: Blood Centers of the Pacific, Peninsula/South Bay Center, Burlingame, CA. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0615-2; b) Platelets, Recall # B-0616-2. CODE a) and b) Unit 4507258 RECALLING FIRM/MANUFACTURER Northern California Community Blood Center, Eureka, CA, by telephone on Aug. 27, 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. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a)Red Blood Cells, Recall # B-0619-2; b) Platelets, Recall # B-0620-2; c) Platelets Pheresis, Leukocytes Reduced, Recall # B-0621-2; d) Recovered Plasma, Recall # B-0622-2. CODE a), b) and d) Unit number 11321-7889; c) Unit number 11322-3486 RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX, by letter on or about Aug. 1, 1999. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that subsequently disclosed previous reactive testing for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION TX and Switzerland. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0623-2. CODE Unit 6543449. RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on Oct. 15, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who had lived in the United Kingdom between 1982 and 1984, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT FlexiLab? Blood Bank and Blood Donor Software (3 versions), Recall # B- 0627-2. CODE Version numbers 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter on Aug. 24, 2001. Firm initiated recall ongoing. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. VOLUME OF PRODUCT IN COMMERCE 3 versions. DISTRIBUTION Nationwide and Canada, United Kingdom, Ireland, Saudi Arabia and Bermuda. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0628-2; b) Recovered Plasma, Recall # B-0629-2. CODE a) and b) Unit 21GS06524. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by fax or letter dated Dec. 5, 2000 or July 25, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0630-2; b) Cryoprecipitate, Recall # B-0631-1; c) Recovered Plasma, Recall # B-0632-2. CODE a), b) and c) Unit 21KL19584 RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by fax or letter dated Feb. 28 or March 9, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Methotrexate, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA and Switzerland. ______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0633-2; b) Cryoprecipitate, Recall # B-0634-2. CODE a) Unit 21KH56059; b) Unit 21KH56059. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by telephone on June 11 and by letter dated June 21, 2001. REASON Blood products, collected from a donor previously deferred for engaging in high-risk behavior, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OR and CA. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0635-2; b) Recovered Plasma, Recall # B-0636-2. CODE a) and b) Unit 21W48577. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by fax or letter dated June 26 or July 6, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who received a blood transfusion within 12 months of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Platelets, Recall # B-0637-2; b) Fresh Frozen Plasma, Recall # B-0638-2. CODE a) and b) Unit J63485. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center,Grand Rapids, MI, by fax dated July 16, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Lipitor, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0639-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0640-2; c) Cryoprecipitated AHF, Recall # B-0641-2; d) Cryoprecipitated AHF, pooled, Recall # B-0642-2; e) Plasma, Recall # B-0643-2; f) Recovered Plasma, Recall # B-0644-2. CODE a) Units 21GZ06659, 21GC79335; b) Units 21KC11868, 21GC88775, 21KC05248; c) Units 21GZ06659, 21KC05248; d) Unit 21KC11868 - pool number 5097; e) Unit 21GC88775; f) Units 21KC11868, 21GZ06659, 21KC05248. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross, Portland, OR, by telephone on April 2 and by letter dated April 11, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking Tamoxifen and Raloxifen, were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units. DISTRIBUTION CA, OR, MD, MA and PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0648-2; b) Platelets, Irradiated, Recall # B-0649-2. CODE a) and b) Unit G53445. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by fax dated May 2, 2001. 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. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0650-2. CODE Unit 21KK32532. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by fax dated Aug. 17, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported living in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0655-2. CODE Unit 7802136 RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on Nov. 20, 2001. Firm initiated recall is complete. REASON Blood product, that tested negative for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but was collected from a donor that previously tested repeatedly reactive for anti-HIV1/2, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0656-2. CODE Unit 3825226. RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., by telephone on Sept. 15, 2001. Firm initiated recall is complete. REASON Blood product, incorrectly tested for anti-HBcore antibody, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0657-2. CODE Units 21KC25927, 21KC25975, 21KC25984, 21KC25993, 21KC25911, 21KC26059, 21KC25904, 21KC25910, 21KC25979, 21KC25981, 21KC26068, 21KC26071, 21KC26000, 21KC26002, 21KC26003, 21KJ59739, 21KJ59743, 21KJ59749, 21KJ59750, 21KJ59751, 21KC26049, 21KC26064, 21KC26045, 21KC26069, 21KJ59717, 21KJ59718, 21KJ59721, 21KJ59732, 21KJ59736, 21KJ59747, 21KC26065, 21KC26073, 21FM71818, 21FM71823, 21FM71829, 21FM71855, 21FT36620, 21GY73884, 21KC25885, 21KC25890, 21KC25892, 21KJ59715, 21KJ59716, 21KJ59728, 21KJ59729, 21KW07539, 21KZ03873, 21KJ59663, 21KM28345, 21KC25943, 21KC25974, 21FM71825, 21FM71837, 21FM71851, 21FZ06573, 21GW33220, 21FM71777, 21GL65904, 21GY73846, 21GY73853, 21GY73879, 21KH59551, 21KL39407, 21Y67612, 21KC25833, 21KC25849, 21KJ59696, 21KR18255, 21KW07524, 21KW07526, 21KW07535, 21KW07538, 21KZ03859, 21KZ03864, 21KZ03866, 21KZ03874, 21KZ03876, 21KZ03877, 21KZ03882 RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by telephone on July 26 and by letter dated Aug. 9, 2001. Firm initiated recall is complete. REASON Blood products, stored at incorrect temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 79 units. DISTRIBUTION WA and OR. _______________________ PRODUCT SAFETRACE TX, Recall # B-0664-2. CODE Versions 1.2.1, 2.0.0, 2.1.0, information systems RECALLING FIRM/MANUFACTURER Global Med Technologies, Inc., El Dorado Hills, CA, by letter dated Sept. 13, 2001. Firm initiated recall is complete. REASON Software performance tests conducted by the manufacturer found that under certain circumstances, compatibility test results may be posted to another patientís record. VOLUME OF PRODUCT IN COMMERCE 3 versions. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall # B-0665-2. CODE Units A213449-1, A213449-2, B205254. RECALLING FIRM/MANUFACTURER Puget Sound Blood Center & Program, Seattle, WA, by letter dated April 16, 2001. Firm initiated recall is complete. REASON Blood products, incorrectly labeled as leukoreduced, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WA. ______________________ PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0668-2. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by letters on Nov. 23, Dec. 7 and 14, 1999, Jan. 5, March 9 and May 18, 2000. Firm initiated recall is ongoing. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. VOLUME OF PRODUCT IN COMMERCE 272 distributed. DISTRIBUTION Nationwide and Internationally _______________________ PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0670-2. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by letters on September 16, 24, October 4, 1999 and May 18, 2000. Firm initiated recall is ongoing. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. VOLUME OF PRODUCT IN COMMERCE 272 distributed. DISTRIBUTION Nationwide and Internationally _______________________ PRODUCT a) Red Blood Cells, Recall # B-0675-2; b) Platelets, Recall # B-0676-2. CODE a) Units W16927, R11341, N03677; b) Unit N03677 RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Tacoma, WA, by telephone on May 2, and by letter dated May 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION WA and MA. _______________________ PRODUCT Recovered Plasma, Recall # B-0679-2. CODE Unit FH80557. RECALLING FIRM/MANUFACTURER Alton Ochsner Medical Foundation Blood Bank, New Orleans, LA, by fax on Dec. 11, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who had an elevated test result for alanine aminotransferase (ALT), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-0680-2. CODE Unit 21GS11414. RECALLING FIRM/MANUFACTURER American National Red Cross, Portland, OR, by letter dated May 21, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor taking Zovirax, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Recovered Plasma, Recall # B-0682-2. CODE Unit FH78204. RECALLING FIRM/MANUFACTURER Alton Ochsner Medical Foundation Blood Bank, New Orleans, LA, by fax on Dec. 11, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who had an elevated test result for alanine aminotransferase (ALT), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a)Red Blood Cells, Recall # B-0684-2; b) Fresh Frozen Plasma, Recall # B-0685-2; c) Recovered Plasma, Recall # B-0686-2. CODE a) and b) Units 04J16048; a) and c) Unit 04R45403. RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA, by letter dated Aug. 2, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had been diagnosed with hepatitis C, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MA, MN and CT. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0688-2; b) Platelets, Recall # B-0689-2; c) Fresh Frozen Plasma, Recall # B-0690-2; d) Recovered Plasma, Recall # b-0691-2. CODE a) Units 04LE22637, 04L07440, 04H76567; b) and c) Unit 04H76567; d) Units 04LE22637, 04H76567. RECALLING FIRM/MANUFACTURER American Red Cross, Dedham, MA, by letter dated July 9, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for hepatitis C, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION MA, MN and NH. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall # B-0692-2. CODE Unit FF85755. RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA, by telephone and letter on Nov. 25, 1998. Firm initiated recall is complete. REASON Blood product, which was labeled as leukoreduced, but failed the quality control specification for white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0695-2; b) Recovered Plasma, Recall # B-0696-2. CODE a) and b) Unit R08059. RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA, by letters dated Sept. 28 and 29, 1998. Firm initiated recall is complete. REASON Blood products, collected from a donor who had a history of sexual contact with an IV drug user, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0697-2; b) Recovered Plasma, Recall # B-0698-2. CODE a) and b) Unit 01GX22089. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by letter dated March 19, 2001. Manufacturer: American Red Cross Blood Services, Albany, NY. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT Source Plasma (For Manufacturing Use Only), Recall # B-0699-2. CODE Units 57232515, 57233208, 57233420, 57233628. RECALLING FIRM/MANUFACTURER SeraCare Acquisitions, Inc., Providence, RI, by telephone on Oct. 29, 2001. Concerrence for firm initiated recall. REASON Blood products, collected from a donor who engaged in high-risk behavior, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA. _____________________ PRODUCT a) Red Blood Cells, Recall # B-0700-2; b) Platelets, Recall # B-0701-2; c) Recovered Plasma, Recall # B-0702-2. CODE a), b) and c) Unit number 13GX33831. RECALLING FIRM/MANUFACTURER The American National Red Cross, Detroit, MI, by letters on Sept. 4 and 12, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on use of certain medications, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MI and CA. _______________________ PRODUCT Reagent Red Blood Cells of the following types: a) Ficin Screening Cells Duet, Recall # B-0703-2; b) Screening Trio, Recall # B-0704-2; c) Panel One, Recall # B-0705-2; d) Ficin Panel One, Recall # B-0706-2; e) Panel Twenty, Recall # B-0707-2. CODE a) lot number 0116088; b) lot numbers 0116124 and 0116125; c) and d) lot number 0123111; e) lot number 0130122. RECALLING FIRM/MANUFACTURER Gamma Biologicals, Inc., Houston, TX, by letters on Feb. 23 and March 12, 2001. Firm initiated recall is complete. REASON Reagent Red Blood Cells, that demonstrated a decrease in strength of the S antigen, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 lots. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0135-2. CODE Unit 22420-0865. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 17, 2001, and by letter dated February 21, 2001. Manufacturer: United Blood Services,Las Vegas, NV. Firm initiated recall is complete. REASON Blood product, collected with an RBC volume below the firmís minimum specification, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. _______________________ PRODUCT Red Blood Cells, Recall # B-0340-2. CODE Unit 7517244. RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, by letter dated June 11, 2001. Firm initiated recall is complete REASON Blood product, collected from a donor who revealed having sex with an individual who had received clotting factor concentrates for a bleeding problem, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0412-2. CODE Unit 03KN11974. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Atlanta, GA, by telephone on June 19 and by letter June 27, 2000. Manufacturer: American Red Cross Blood Services, Daytona Beach, FL. Firm initiated recall is complete. REASON Blood product, which was not quarantined after receiving post donation information concerning illness, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0414-2; b) Recovered Plasma B-0415-2. CODE a) and b) Unit G00130. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letter on July 27, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm inspection had not been documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0416-2; b) Platelets, Recall # B-0417-2; c) Recovered Plasma, Recall # B-0418-2 CODE a), b) and c) Unit FL06665 RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letter on August 27, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had an elevated body temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL and Switzerland. _____________________ PRODUCT Various Human Freeze Dried Bone and/or Frozen Human Tissue, grafts including: Cancellous Chips, 40cc; Cancellous Chips, 30cc; Cancellous Chips, 60cc; Cancellous Chips, 90cc Cancellous Cubes, 40cc; Corticocancellous Chips, 40cc; Frozen Achilles Tendon with Bone Block; Frozen Bisected Femoral Shaft; Frozen Bisected Patella Ligament; Frozen Femoral Head; Frozen Humeral Head; Fascia Lata Medium (Freeze Dried); Fascia Lata, Regular (Freeze Dried); Fascia Lata Small (Freeze Dried); Iliac Crest Wedge Size 5cm, Recall # B-0476-2. CODE Graft Identificaiton Numbers (45 grafts); 98-1302-022, 98-1302-023, 99-0893-004, 99-0893-005, 99-0893-007, 99-0893-009, 98-1302-015, 99-0893-008, 99-0893-008, 98-1302-010, 98-1302-001, 98-1302-004, 98-1302-024, 98-1302-025, 98-1302-026, 98-1302-027, 98-1302-028, 98-1302-029, 98-1302-030, 98-1302-031, 98-1302-032, 98-1302-033, 98-1302-034, 98-1302-035, 99-0893-013, 98-1302-014, 98-1302-007, 98-1302-005, 98-1302-006, 98-1302-008, 98-1302-016, 98-1302-017, 98-1302-009, 99-0893-010, 99-0893-015, 98-1302-002, 99-0893-002, 99-0893-003, 98-1302-011, 98-1302-012, 98-1302-018, 98-1302-019, 98-1302-020, 98-1302-021, 98-1302-036, 98-1302-003. RECALLING FIRM/MANUFACTURER Recalling Firm: New England Organ Bank, Newton, MA, by letter on Nov. 19, 2001. Processor: LifeNet, Virginia Beach, VA. Firm initiated recall is ongoing. REASON Various tissues for transplant which were collected from donors who had not been properly evaluated. VOLUME OF PRODUCT IN COMMERCE 45 grafts. DISTRIBUTION MA, MN, RI, LA and MN. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0498-2. CODE Unit 10714-0510. RECALLING FIRM/MANUFACTURER United Blood Services, Scottsdale, AZ, by telephone on Sept. 28, and by letter dated Oct. 16, 2001. REASON Blood product, collected from a donor who had a history of ulcerative colitis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT a) Platelets, Pheresis, Recall # B-0557-2; b) Fresh Frozen Plasma, Recall # B-0558-2. CODE a) and b) Unit 004-1786. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated February 27, 2001. Manufacturer: United Blood Services, Tucson, AZ. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm inspection was incorrectly performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _______________________ PRODUCT Source Plasma, Recall # B-0559-2. CODE Unit YA-62454. RECALLING FIRM/MANUFACTURER Recalling Firm: Pyramid Biological Corporation, Van Nuys, CA, by fax dated April 10, 2001. Manufacturer: Pyramid Biological Corporation, San Diego, CA Firm initiated recall is complete. REASON Blood product, collected from a donor who was not asked the medical history questions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________ PRODUCT Source Plasma, Recall # B-0560-2. CODE Units VA-87118, VA-87173, VA-87365 RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA, by fax dated May 18, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor whose medical history was not properly obtained, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL. _______________________ PRODUCT a) Whole Blood Irradiated, Recall # B-0561-2; b) Red Blood Cells, Irradiated, Recall # B-0562-2; c) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0563-2. CODE a) Units G27471, G25225, G25226; b) Units G25795, G25387, G25318, G25307, G23298, G21835, G21834, G19991, G17578, G05765, G05734, G05728, G05045; c) Unit G19935. RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Rockford, IL, by letters dated August 28 and September 4, 2001. Firm initiated recall is complete. REASON Blood products, labeled with an extended expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 17 units. DISTRIBUTION IL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0575-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0576-2. CODE a) Unit numbers 3386350, 3386351, 3386352, 3386355, 3386359, 3386360, 3386361, 3386363, and 3386364; b) Unit number 3386349. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by letter dated June 17, 1998. Firm initiated recall is complete. REASON Blood products, labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION TX and AK. _______________________ PRODUCT Red Blood Cell, Irradiated, Recall # B-0588-2. CODE Unit C78800 RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by telephone on Sept. 7, 2001. Firm initiated recall is complete. REASON Blood product, which may have been stored at unacceptable temperatures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Recall # B-0590-2. CODE Unit numbers G80070, G01358, G30163, and G31338. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by letter on December 15, 2000. Firm initiated recall is complete. REASON Blood products, that tested positive for unexpected antibodies to red blood cell antigens, but were labeled negative for unexpected antibodies, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MI. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-0591-2. CODE Unit number 22418-6594. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Dec. 19, 2000. Manufacturer: Blood Systems, Inc.,Las Vegas, NV. Firm initiated recall is complete. REASON Blood product, that did not have a final platelet count performed as required by standard operating procedures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. _______________________ PRODUCT Platelets, Recall, Recall # B-0595-2; Platelets Irradiated, Recall # B-0596-2. CODE a) Unit numbers 3576150, 3576151, 3576152, 3576153, 3576156, 3576157, 3576158, 3576159, 3576160, 3576165, 3576166, 3576167, 3576224, 3576225, 3576226, 3576229, 3576230, 3576231, 3576232, 3576233, 3576235, 3576236, 3576237 (distributed as 2 split units), 3576240, 3577660, 3577661 (distributed as 2 split units), 3577662 (distributed as 2 split units), 3611941, 3611943, 3611944, 3611945, 3611946, 3611947, 3611948, 3611949, 3611951, 3621939, 3621941, 3621942, 3621944, 3625332, 3625333, 3625334, 3625335, 3625336, 3625337, 3625338, and 3625339 b) Unit numbers 3611942 and 3576163. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by letter on May 27, 1999. Firm initiated recall is complete. REASON Blood products, manufactured from units of Whole Blood collected and/or stored at incorrect temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 53 units DISTRIBUTION TX, NY and LA _______________________ PRODUCT Whole Blood, Recall # B-0612-2. CODE Unit 6614366. RECALLING FIRM/MANUFACTURER Inland Northwest Blood Center, Spokane, WA, by telephone on April 24 and by letter dated May 7, 2001. Firm initiated recall is complete. REASON Blood product, collected in expired blood collection bag, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION ID. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0613-2; b) Fresh Frozen Plasma, Recall # B-0614-2. CODE a) and b) Units 22419-3587, 22419-3588 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Jan. 4, 2001. Manufacturer: United Blood Services, Las Vegas, NV. Firm initiated recall is complete. REASON Blood products, labeled with an incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION NV. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0617-2. CODE Unit number 22420-1039. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Jan. 9, 2001. Manufacturer: Blood Systems, Inc., Las Vegas, NV. Firm initiated recall is complete. REASON Blood product that was out of controlled storage for more than 30 minutes was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. _______________________ PRODUCT Red Blood Cells, Pheresis, Recall # B-0624-2. CODE Unit G05495. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by fax on Sept. 25, 2000. Firm initiated recall is complete. REASON Blood product, collected in an expired blood collection bag, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0625-2. CODE Unit G06101 RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by fax on Oct. 3, 2000. Firm initiated recall is complete. REASON Blood product, which was stored at unacceptable temperatures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells, Recall # B-0647-2. CODE Unit 21KH57409. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by telephone and letter dated July 10, 2001. Firm initiated recall is complete. REASON Blood product, collected in an expired blood collection bag, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT Gamma ReACT Test Strips, Recall # B-0652-2. CODE Lot number RGS181 RECALLING FIRM/MANUFACTURER Gamma Biologicals, Inc., Houston, TX, by letter or fax dated Dec. 29, 2000. Firm initiated recall is complete. REASON Test Strips, which were found to cause false-positive test results to occur in identifying unexpected IgG red cell antibodies, were distributed. VOLUME OF PRODUCT IN COMMERCE 135 units DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT a) VWRbrand Sodium Chloride Solution, 0.85% w/v, Aqueous; b) EM Science Brand Immunosaline c) EM Science Brand Sodium Chloride Solution Recall # B-0653-2. CODE a) 1050, 4/30/2002 0340, 4/30/2002 0285, 7/31/2001 0150, 2/28/2001 0326, 7/31/2001 b) 1050, 4/30/2002 0340, 4/30/2002 0285, 7/31/2001 0150, 2/28/2001 c) 0300, 7/31/2001 RECALLING FIRM/MANUFACTURER EM Science, Gibbstown, NJ, by fax dated Feb. 22, 2001. Firm initiated recall is complete. REASON Blood bank saline (0.85% w/v Sodium Chloride), used for immunohematologic testing, is causing weak false positive test results. VOLUME OF PRODUCT IN COMMERCE 10 lots DISTRIBUTION PA, NC and Canada. _______________________ PRODUCT Immunosaline, Sodium Chloride, 0.85, w/v, Recall # B-0654-2. CODE Lots 1065, 1099, 1115. RECALLING FIRM/MANUFACTURER EM Science, Gibbstown, NJ, by letter dated June 5, 2001. Firm initiated recall complete. REASON Reagents, which exhibited an absent or weak positive agglutination reaction when used in S antigen testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 915 Units DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0658-2; b) Red Blood Cells, Leukocytes Removed, Recall # B-0659-2; c) Fresh Frozen Plasma, Recall # B-0660-2; d) Cryoprecipitated AHF, pooled, Recall # B-0661-2; e) Cryo-Poor Frozen, Recall # B-0662-2; f) Source Plasma, Recall # B-0663-2. CODE a) Unit GL68927, GL68869, GX35742, GX40022; b) Unit GL69489; c) Unit GL68869; d) Unit GX35742 pool # G04572; e) Units GX35742, GX40022; f) Units GL69489, GL68927. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by telephone and by letter dated June 8, 2001. REASON Blood products, incorrectly tested for ALT (Alanine Aminotransferase), were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION CA. _______________________ PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0666-2. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by letter on Sept. 18, 2000. Firm initiated recall ongoing. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. VOLUME OF PRODUCT IN COMMERCE 273 distributed. DISTRIBUTION Nationwide and Internationally _______________________ PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0667-2. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by letter on Feb. 10, 2000. Firm initiated recall is ongoing. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. VOLUME OF PRODUCT IN COMMERCE 270 distributed. DISTRIBUTION Nationwide and Internationally _______________________ PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0669-2. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by letters on Nov. 23, Dec. 7 and 14, 1999 and Jan. 5, March 18 and May 18, 2000. Firm initiated recall is ongoing. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. VOLUME OF PRODUCT IN COMMERCE 272 distributed. DISTRIBUTION Nationwide and Internationally _______________________ PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0671-2. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by letters on Sept. 16, 24, Oct. 4 and May 18, 1999. Firm initiated recall is ongoing. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. VOLUME OF PRODUCT IN COMMERCE 272 distributed. DISTRIBUTION Nationwide and Internationally _______________________ PRODUCT Source Plasma, Recall # B-0672-2. CODE Unit VA-93464. RECALLING FIRM/MANUFACTURER Pyramid Biologicals Corporation, Van Nuys, CA, by letter dated May 7, 2001. Firm initiated recall is complete. REASON Source Plasma, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-0673-2. CODE Unit VP-26856. RECALLING FIRM/MANUFACTURER Pyramid Biologicals Corporation, Van Nuys, CA, by fax on June 27, 2001. Firm initiated recall is complete. REASON Source Plasma, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _______________________ PRODUCT Source Plasma, Recall # B-0674-2. CODE Unit VA-92749. RECALLING FIRM/MANUFACTURER Pyramid Biologicals Corporation, Van Nuys, CA, by letter dated June 22, 2001. Firm initiated recall is complete. REASON Source Plasma, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NJ. _______________________ PRODUCT Common Mugwort Allergenic Extract, 5 ML, Recall # B-0678-2. CODE Lot B910081A. RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, OH, by letter dated Nov. 26, 2001. Firm initiated letter is complete. REASON Allergenic extract labeled with an extended expiration date was distributed. VOLUME OF PRODUCT IN COMMERCE 1 vial. DISTRIBUTION PA. _______________________ PRODUCT Recovered Plasma, Recall # B-0681-2. CODE Unit G54662. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by fax on Sept. 21, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who had taken the drug Colbenemid, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________ PRODUCT Coagulation Factor IX (Human), Mononine? IX, Monoclonal Antibody Purified, Recall # B-0683-2. CODE Lot number X29601. RECALLING FIRM/MANUFACTURER Aventis Behring, L.L.C., Kankakee, IL, by telephone and fax on July 31, and by letter on Aug. 12,2001. Firm initiated recall is complete. REASON Coagulation Factor IX that failed potency testing during stability monitoring at the five month time point was distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION Nationwide _______________________ PRODUCT ABS QC Antibody reagent (a component of the ABS QC Test System), Recall # B-0687-2. CODE Lot numbers 131300 and 131310 RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA, by fax on or about June 17, 2001. Firm initiated recall is complete. REASON Quality control (QC) reagent was distributed that experienced an increased incidence of QC test failures. VOLUME OF PRODUCT IN COMMERCE 2 lots. DISTRIBUTION Nationwide, Canada, Mexico, Portugal, Taiwan, Hong Kong, Japan and Italy _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0693-2; b) Fresh Frozen Plasma, Recall # B-0694-2. CODE a) and b) Unit 01Y35975. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, West Henrietta, NY, by letters dated May 4 and 10, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking Doxycycline for prophylactic use, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0712-2. CODE Unit 18FK51353. RECALLING FIRM/MANUFACTURER American Red Cross, Great Lakes Region, Lansing, MI, by telephone on April 11, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor taking the drug Welbutrin, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT 1) a non-prescription gauze, labeled in part: "NU GAUZE General-Use Sponges 2 in. x 2 in. - 4ply 2 SPONGES STERILE REORDER 2338 Johnson & Johnson Medical Division of Ethicon, Inc. Arlington, TX". 2) a non-prescription gauze, labeled in part: "MIRASORB Sponges 2 in. x 2 in. - 4ply 2 SPONGES STERILE REORDER 602318 Johnson & Johnson Medical Division of Ethicon, Inc. Arlington, TX". Both products are packaged 1500 to a case, Recall # Z-0334-02/Z-0335-02. CODE 1) Nu Gauze: Product code 2338 (on front panel of label) and lots: 2001 10 1, 2001 10 2, 2001 10 3, 2001 10 A, 2001 10 B, 2001 10 C, 2001 10 D (on back of package). 2) Mirasorb: Product code 602318 (on front panel of label) and lots: 2001 10 1, 2001 10 2, 2001 10 3 (on back of package). RECALLING FIRM/MANUFACTURER Recalling Firm: Johnson & Johnson Medical, Div. of Ethicon, Inc. Arlington, TX, by letters on Oct. 26, 2001. Manufacturer: Johnson & Johnson Medical, Div. of Ethicon, Inc. Sherman, TX. Firm initiated recall is ongoing. REASON Seal Integrity - possibly non-sterile device. VOLUME OF PRODUCT IN COMMERCE 438,000. DISTRIBUTION Nationwide. _______________________ PRODUCT Hill-Rom Advanta 1600 series retractable med-surg beds with the optional accessory outlet. Recall # Z-0336-02. CODES All units shipped between April 2000 and March 2001, Serial # A334AB0065, B087AB1863, B087AB1865, B094AB1951, B094AB1952, B094AB1953, B094AB1954, B094AB1955, B094AB1956, B094AB1957, B094AB1958, B094AB1959, B094AB1960, B094AB1962, B094AB1963, B095AB1974, B095AB1975, B095AB1976, B095AB1977, B095AB1978, B095AB1982, B095AB1983, B095AB1984, B095AB1985, B095AB1986, B095AB1987, B095AB1988, B095AB1989, B096AB1996, B096AB1997, B096AB1998, B096AB1999, B096AB2000, B096AB2001, B096AB2003, B096AB2006, B096AB2007, B096AB2008, B097AB2026, B097AB2027, B097AB2032, B098AB2033, B098AB2034, B098AB2035, B098AB2039, B098AB2040, B098AB2041, B098AB2042, B098AB2043, B098AB2044, B098AB2045, B098AB2050, B098AB2051, B098AB2052, B098AB2053, B104AB2124, B104AB2125, B104AB2126, B104AB2127, B104AB2128, B104AB2129, B104AB2130, B104AB2131, B104AB2132, B104AB2133, B104AB2134, B104AB2135, B104AB2136, B104AB2137, B137AB2981, B140AB3051, B140AB3054, B143AB3096, B143AB3097, B143AB3101, B143AB3103, B143AB3106, B143AB3108, B143AB3113, B143AB3115, B143AB3116, B144AB3147, B144AB3148, B144AB3150, B144AB3152, B144AB3153, B144AB3157, B144AB3158, B144AB3161, B144AB3163, B145AB3195, B145AB3196, B145AB3197, B146AB3243, B146AB3246, B146AB3248, B146AB3256, B146AB3257, B146AB3263, B146AB3267, B146AB3271, B157AB3567, B157AB3571, B161AB3757, B172AB4086, B173AB4110, B173AB4114, B173AB4115, B173AB4116, B173AB4117, B173AB4120, B173AB4121, B173AB4122, B174AB4151, B174AB4152, B174AB4153, B174AB4154, B174AB4155, B174AB4156, B174AB4157, B174AB4158, B174AB4159, B174AB4160, B174AB4161, B175AB4192, B178AB4200, B178AB4203, B178AB4206, B178AB4207, B178AB4208 ,B178AB4212, B178AB4213, B178AB4214, B179AB4235, B179AB4236, B179AB4239, B179AB4241, B179AB4244, B179AB4245, B182AB4330, B182AB4333, B207AB4744, B207AB4751, B207AB4753, B207AB4758, B207AB4759, B208AB4764, B208AB4767, B208AB4770, B208AB4773, B208AB4777, B208AB4781, B208AB4789, B208AB4790, B208AB4794, B208AB4800, B208AB4801, B208AB4803, B208AB4806, B208AB4809, B208AB4811, B209AB4814, B209AB4816, B209AM5058, B209AM5059, B216AB5070, B216AB5073, B216AB5075, B216AB5077, B216AB5080, B216AB5081, B216AB5083, B216AB5084, B216AB5087, B216AB5088, B216AB5092, B216AB5093, B217AB5121, B217AB5123, B217AB5125, B217AB5126, B217AB5128, B217AB5131, B217AB5132, B217AB5133, B217AB5135, B222AB5268, B222AB5271, B222AB5274, B222AB5282, B222AB5283, B222AB5286, B222AB5291, B222AB5292, B222AB5294, B223AB5326, B223AB5328, B223AB5329, B223AB5334, B223AB5338, B223AB5343, B223AB5345, B223AB5347, B223AB5349, B224AB5375, B224AB5376, B224AB5379, B224AB5382, B231AB5672, B231AB5681, B232AB5738, B232AB5746, B232AB5752, B232AB5753, B232AB5755, B232AB5758, B232AB5761, B232AB5765, B232AB5768, B232AB5787, B234AB5805, B234AB5806, B234AB5814, B235AB5858, B235AB5859, B235AB5869, B235AB5870, B235AB5872, B235AB5873, B235AB5874, B235AB5883, B235AB5887, B235AB5890, B235AB5895, B236AB5899, B236AB5901, B236AB5903, B236AB5904, B236AB5922, B236AB5923, B236AB5928, B236AB5929, B236AB5930, B236AB5933, B236AB5939, B236AB5941, B236AB5947, B237AB5959, B237AB5961, B237AB5964, B237AB5966, B237AB5975, B237AB5977, B237AB5978, B237AB5980, B237AB5990, B237AB6001, B237AB6004, B238AB6005, B238AB6006, B238AB6009, B238AB6010, B238AB6011, B239AB6045, B253AB6636, B253AB6637, B253AB6638, B253AB6639, B253AB6640, B253AB6641, B253AB6642, B253AB6643, B253AB6644, B253AB6645, B253AB6646, B253AB6647, B253AB6648, B255AB6649, B255AB6650, B255AB6651, B255AB6652, B255AB6653, B255AB6654, B255AB6655, B255AB6656, B255AB6657, B255AB6658, B255AB6659, B255AB6660, B255AB6661, B255AB6662, B255AB6664, B255AB6666, B255AB6699, B255AB6700, B255AB6701, B255AB6702, B255AB6703, B255AB6704, B255AB6705, B255AB6706, B255AB6707, B255AB6708, B256AB6709, B256AB6710, B256AB6711, B256AB6712, B256AB6713, B256AB6714, B256AB6715, B256AB6716, B256AB6717, B256AB6718, B256AB6719, B256AB6720, B256AB6721, B256AB6722, B256AB6723, B256AB6724, B256AB6725, B256AB6726, B256AB6727, B256AB6728, B256AB6729, B256AB6730, B256AB6734, B256AB6735, B256AB6736, B256AB6737, B256AB6738, B256AB6739, B256AB6740, B256AB6741, B256AB6742, B256AB6743, B256AB6744, B256AB6745, B256AB6746, B256AB6748, B256AB6750, B264AB7297, B264AB7299, B264AB7314, B264AB7321, B264AB7324, B264AB7325, B264AB7328, B264AB7340, B264AB7351, B264AB7354, B265AB7388, B265AB7392, B265AB7402, B272AB7797, B272AB7805, B272AB7806, B272AB7807, B272AB7809, B272AB7812, B272AB7821, B272AB7823, B272AB7824, B272AB7825, B273AB7830, B273AB7842, B273AB7849, B273AB7851, B273AB7853, B273AB7854, B273AB7859, B273AB7860, B273AB7861, B273AB7864, B273AB7865, B273AB7866, B273AB7870, B273AB7875, B273AB7879, B276AB7899, B276AB7901, B276AB7909, B276AB7912, B276AB7916, B276AB7917, B276AB7921, B276AB7923, B276AB7925, B276AB7930, B276AB7931, B276AB7934, B276AB7942, B276AB7943, B276AB7945, B283AB8324, B283AB8328, B283AB8333, B283AB8334, B283AB8342, B283AB8344, B283AB8346, B283AB8348, B284AB8355, B284AB8360, B284AB8371, B284AB8372, B284AB8373, B284AB8374, B284AB8384, B284AB8386, B284AB8387, B284AB8391, B284AB8400, B284AB8402, B284AB8404, B284AB8407, B284AB8407, B284AB8410, B284AB8411, B284AB8416, B284AB8417, B284AB8418, B284AB8423, B284AB8424, B284AB8429, B284AB8436, B284AB8446, B285AB8453, B285AB8461, B285AB8468, B285AB8470, B285AB8471, B285AB8475, B285AB8479, B285AB8484, B285AB8488, B285AB8490, B285AB8495, B285AB8498, B285AB8506, B285AB8510, B285AB8511, B285AB8512, B285AB8513, B285AB8516, B285AB8523, B285AB8524, B285AB8528, B285AB8531, B285AB8533, B285AB8535, B285AB8536, B286AB8537, B286AB8539, B286AB8541, B286AB8545, B286AB8549, B286AB8550, B286AB8552, B286AB8553, B286AB8556, B286AB8557, B286AB8565, B286AB8566, B286AB8568, B286AB8570, B286AB8571, B286AB8572, B286AB8573, B286AB8581, B286AB8587, B286AB8588, B286AB8589, B286AB8592, B286AB8594, B286AB8596, B286AB8602, B286AB8605, B286AB8608, B286AB8616, B286AB8620, B286AB8621, B286AB8622, B286AB8623, B286AB8627, B286AB8628, B287AB8634, B287AB8637, B287AB8639, B287AB8643, B287AB8646, B287AB8648, B287AB8649, B287AB8653, B287AB8655, B287AB8658, B287AB8661, B287AB8666, B287AB8669, B287AB8670, B287AB8680, B287AB8681, B287AB8683, B287AB8685, B287AB8687, B287AB8688, B287AB8692, B287AB8695, B287AB8696, B287AB8703, B287AB8707, B287AB8710, B287AB8716, B287AB8722, B287AB8723, B287AB8724, B287AB8726, B287AB8730, B287AB8731, B288AB8734, B288AB8738, B288AB8740, B288AB8745, B290AB8747, B290AB8750, B290AB8754, B290AB8757, B290AB8758, B290AB8766, B290AB8767, B294AB9186, B294AB9190, B294AB9192, B294AB9194, B294AB9197, B294AB9198, B294AB9203, B294AB9209, B294AB9211, B298AB9400, B298AB9404, B298AB9408, B299AB9473, B307AB9978, B311AB0232, B312AB0234, B312AB0240, B312AB0242, B312AB0244, B312AB0245, B312AB0254, B312AB0255, B312AB0256, B312AB0261, B312AB0264, B312AB0271, B312AB0274, B312AB0275, B312AB0280, B312AB0281, B312AB0284, B312AB0296, B318AB0663, B322AB0951, B327AB1113, B327AB1115, B327AB1116, B327AB1119, B327AB1121, B327AB1122, B327AB1126, B327AB1127, B327AB1132, B327AB1133, B327AB1135, B327AB1136, B327AB1138, B327AB1140, B327AB1141, B327AB1142, B327AB1145, B327AB1147, B327AB1148, B327AB1150, B336AB1357, B336AB1358, B346AB1898, B346AB1900, B346AB1903, B346AB1907, B346AB1908, B346AB1910, B346AB1913, B346AB1918, B346AB1922, B347AB1929, B347AB1932, B347AB1935, B347AB1937, B347AB1940, B347AB1945, B347AB1946, B347AB1949, B347AB1954, B347AB1958, B347AB1960, B347AB1963, B347AB1964, B347AB1966, B347AB1972, B347AB1976, B347AB1977, B348AB1978, B348AB1980, B348AB1988, B348AB1989, B348AB1990, B348AB1993, B348AB1995, B348AB2000, B348AB2003, B348AB2004, B348AB2005, B353AB2139, B353AB2145, B353AB2150, B354AB2176, B354AB2180, B354AB2181, B354AB2182, B354AB2183, B354AB2184, B354AB2185, B354AB2186, B354AB2191, B354AB2192, B354AB2197, B354AB2203, B354AB2204, B354AB2215, B354AB2217, B354AB2218, B354AB2222, B354AB2228, B354AB2230, B355AB2232, B355AB2237, B355AB2241, C002AB2405, C002AB2409, C002AB2411, C002AB2416, C002AB2417, C002AB2423, C002AB2427, C003AB2431, C003AB2435, C003AB2439, C003AB2442, C003AB2444, C003AB2448, C003AB2449, C003AB2453, C003AB2455, C003AB2460, C003AB2462, C004AB2465, C004AB2467, C004AB2471, C008AB2565, C008AB2566, C008AB2570, C008AB2575, C008AB2576, C008AB2578, C008AB2584, C008AB2585, C008AB2587, C008AB2590, C008AB2595, C008AB2597, C009AB2601, C009AB2603, C009AB2608, C009AB2612, C009AB2615, C009AB2616, C009AB2618, C009AB2619, C009AB2624, C009AB2626, C009AB2627, C009AB2635, C009AB2637, C009AB2638, C009AB2643, C009AB2644, C009AB2648, C009AB2650, C009AB2652, C009AB2655, C009AB2659, C011AB2671, C011AB2675, C011AB2677, C011AB2679, C011AB2682, C011AB2689, C011AB2690, C011AB2691, C011AB2692, C011AB2695, C011AB2700, C011AB2704, C011AB2706, C011AB2707, C011AB2710, C011AB2717, C011AB2719, C016AB2810, C017AB2842, C024AB3045, C024AB3049, C024AB3052, C024AB3055, C024AB3058, C024AB3062, C024AB3063, C024AB3067, C024AB3070, C024AB3073, C025AB3074, C025AB3077, C025AB3080, C025AB3084, C025AB3087, C030AB3212, C036AB3376, C036AB3379, C036AB3384, C036AB3386, C036AB3387, C036AB3389, C037AB3393, C037AB3398, C037AB3399, C037AB3403, C037AB3407, C037AB3408, C037AB3411, C037AB3414, C037AB3419, C037AB3422, C037AB3424, C037AB3427, C037AB3432, C037AB3434, C037AB3447, C037AB3448, C037AB3451, C037AB3453, C037AB3457, C037AB3461, C04B3593, C052AB3877, C052AB3880, C052AB3882, C052AB3886, C052AB3887, C052AB3890, C052AB3893, C052AB3894, C052AB3895, C053AB3899, C053AB3902, C053AB3903, C053AB3906, C053AB3907, C053AB3909, C053AB3912, C053AB3915, C053AB3916, C053AB3918, C053AB3920, C053AB3923, C053AB3924, C053AB3926, C053AB3927, C053AB3930, C053AB3932, C053AB3934, C053AB3937, C053AB3938, C053AB3940, C053AB3942, C053AB3943, C053AB3944, C053AB3945, C053AB3946, C053AB3947, C053AB3948, C053AB3949, C053AB3950, C053AB3951, C053AB3952, C053AB3953, C053AB3954, C053AB3955, C053AB3958, C057AB4004, C057AB4007, C057AB4014, C057AB4020, C057AB4026, C057AB4032, C057AB4034, C058AB4055, C058AB4061, C058AB4067, C058AB4073, C058AB4079, C058AB4085, C058AB4094, C059AB4112, C059AB4119, C059AB4125, C059AB4131, C059AB4137, C059AB4144, C059AB4148, C060AB4157, C060AB4167, C060AB4168, C060AB4179, C060AB4184, C060AB4190, C060AB4196, C060AB4206, C060AB4210, C060AB4215, C061AB4223, C061AB4228, C061AB4238, C061AB4262, C066AB4395, C066AB4398, C066AB4399, C066AB4403, C066AB4405, C066AB4410, C066AB4411, C067AB4442, C067AB4443, C067AB4449, C067AB4451, C067AB4454, C067AB4459, C067AB4462, C067AB4464, C067AB4466, C067AB4471, C068AB4500, C068AB4505, C068AB4509, C068AB4511, C068AB4514, C068AB4521, C068AB4530, C071AB4551, C073AB4702, C073AB4703, C073AB4707, C073AB4710, C074AB4724, C074AB4729, C074AB4731, C074AB4734, C074AB4737, C074AB4740, C074AB4744, C074AB4747, C074AB4752, C078AB4852, C087AB5253, C092AB5412, C094AB5506. RECALLING FIRM/MANUFACTURER Hill-Rom Company, Batesville, IN, by letter dated Oct. 26, 2001. Firm initiated recall is ongoing. REASON Optional accessory outlet cable not secured properly and may be damaged with use and cause fire. VOLUME OF PRODUCT IN COMMERCE 932 units. DISTRIBUTION Nationwide and Canada. ______________________ PRODUCT Abiomed BVS 5000t Bi-Ventricular Support System Transport/Backup Console. Recall # Z-0440-02. CODE Serial Numbers: 3019 through 3050, 3052, 3053, 3055 and 3056. RECALLING FIRM/MANUFACTURER Abiomed, Inc., Danvers, MA, by fax on Oct. 10, 2001. Firm initiated recall is complete. REASON Console's audible alarm may fail to signal. VOLUME OF PRODUCT IN COMMERCE 36. DISTRIBUTION Nationwide. _______________________ PRODUCT Cordis Nylex 5F Flush Angiographic Catheters (Product Number 526510) and Cordis Tempo 4F Selective Diagnostic Catheters (Product Numbers 4514**VO), Recall # Z-0442-02/0443-02. CODE Product Number 526510, Lot Number R0401411 451442VO Lot Number 50401670 451443VO Lot Number W0401196 451413V0 Lot Number W0401377 RECALLING FIRM/MANUFACTURER Recalling Firm: Cordis Corp. Miami Lakes, FL, by letter on June 1, 2001. Manufacturer: Cordis Europa Roden, Netherlands. Firm initiated recall is ongoing. REASON Increased tip stiffness with a potential for vessel damage. VOLUME OF PRODUCT IN COMMERCE 135. DISTRIBUTION Nationwide _______________________ PRODUCT 6.5EC10 Disposable Biopsy Guide, P/N 5269613, Recall # Z-0445-02. CODE Mfg date 2000.07. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions USA, Inc Issaquah, WA, by letter dated May 2001. Manufacturer: Civco Kalona, IA., Firm initiated recall is complete. REASON Disposable biopsy guide does not fit properly on the transducer and may shift. VOLUME OF PRODUCT IN COMMERCE 251 boxes each containing 20 disposable biopsy guides. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Hemoliance Brain Thromboplastin (HBT), 12 mL: Prothrombin Time Test. Recall # Z-0449-02. CODE Part No. 49732400 Lot No.: N0415055 Exp. Date: 08/04. RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Laboratory Co. Lexington, MA, by E-mail on Sept. 6, and by telephone and fax on Sept. 7, 2001. Manufacturer: Instrumentation Laboratory Co. Orangeburg, NY. Firm initiated recall is ongoing. REASON International Sensitivity Index (ISI) incorrectly assigned for Prothrombin Time. VOLUME OF PRODUCT IN COMMERCE 559 kits. DISTRIBUTION FL. _______________________ PRODUCT Marisa Patient Lift, Non-AC Powered; Arjo Inc., Roselle, IL 60172 Model KGB2000-US, Marisa Complete with Jib and no Scale Model KGB2100-US, Marisa Complete with Jib and Scale, Recall # Z-0460-02. CODE Models KGB2000-US and KGB2100-US, serial numbers GB 4697 792463 001 to GB 1099 819522 010. RECALLING FIRM/MANUFACTURER Recalling Firm: Arjo, Inc., Roselle, IL, by letter dated Dec. 14, 2001. Manufacturer: Arjo Limited Gloucester, United Kingdom. Firm initiated recall is ongoing. REASON Improper alignment of jib assembly to lift carriage. VOLUME OF PRODUCT IN COMMERCE 1,431 units. DISTRIBUTION AZ, WI and VA. _______________________ PRODUCT Marquest Ventilator Circuit w/Volume Vent Manifold. Recall # Z-0461-02. CODE Product Code Lot# 1561133 #493N 1570035 #838L 156355 #260N, 156P, 338M, 339M, 354N, 368M, 419N, 461M, 419N, 525M, 461M, 625N, 638M, 787M, 880L, 952N 1570240 #721M, 776N 1571134 #430N, 526M, 600M, 665N, 990L, 1572099 #175M, 291M, 643M, 312N, 821N, 854M, 1572336 #494N 1576689 #865M 157355 #152M, 190P, 313M, 575N, 722M, 860M 1576712 #215N, 231P, 282M, 372N, 445M, 525N, 564M, 784M, 889L, 800L, 990N 157516 #827N 1576006 #276N, 283M, 497M, 433N, 567M, 630M, 691M 1576380 #102N 4P78ENSP #950N 4S78EXSP #292M, 668N 6463 #195M, 351N, 706N, 361L, 707N, 456M, 826N, 572M 870K, 704N, 965L, 705N, 6464 #112N, 154M, 196M, 313N, 683N, 349M, 953M, 363L, 966L, 365M, 968M, 457M, 573N. RECALLING FIRM/MANUFACTURER Marquest Medical Products, Inc. Englewood, CO, by letter on Aug. 15, 2001. Firm initiated recall is ongoing. REASON Cracked Exhalation Valve Caps on ventilator circuits. VOLUME OF PRODUCT IN COMMERCE 32130 units. DISTRIBUTION Nationwide and Argentina, Canada, Japan, Saudi Arabia and Singapore. _______________________ PRODUCT Atrium water seal chest drain, Ocean 2002 with preconnected ATS blood bag. Recall # Z-0462-02. CODE Model 2250 Order Number: 2002-057 Lot Numbers: P990049, P990086, P990083, 002042-057, 002160-057, 002175-057. RECALLING FIRM/MANUFACTURER Atrium Medical Corp. Hudson, NH, by fax on Sept. 8, 2000. Firm initiated recall is ongoing. REASON Seal integrity of Blood Bag compromised resulting in blood leakage. VOLUME OF PRODUCT IN COMMERCE 498 units. DISTRIBUTION IA and VA. _______________________ PRODUCT Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System, Recall # Z-0463-02. CODE Version 2.2a Catalog # PL01. RECALLING FIRM/MANUFACTURER Recalling Firm: Biochem Immunosystems (U.S.), Inc. Allentown, PA, by sending software correction diskettes and notifications on Aug. 15 and by telephone on Aug. 16, 2001. Manufacturer: BioChem ImmunoSystems Italia Spa Guidonia Montecello, Rome. Firm initiated recall is complete. REASON Samples were not picked up and added to the dilution tube. VOLUME OF PRODUCT IN COMMERCE 17 units. DISTRIBUTION Nationwide. _______________________ PRODUCT VISION T-22 Gamma Camera System, Recall # Z-0464-02. CODE Serial Numbers 1 thru 50. RECALLING FIRM/MANUFACTURER Recalling Firm: G. E. Medical Systems Twinsburg, OH, by letter on Aug. 27, 2001. Manufacturer: Hitachi Medical Corp. Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing. REASON The collimator bolts may fail and allow the collimator to drop. Injury may result. VOLUME OF PRODUCT IN COMMERCE 47. DISTRIBUTION Nationwide. _______________________ PRODUCT Resuscitaion bag component in an assembled custom surgical kit, Non sterile, lableled in part: "open heart sgl pull items jewish hosp Healthcare, lot #, expiration, reorder # ht0586. Note that only the Resuscitaion bag component was under recall and not the entire kit. Recall # Z-0466-02. CODE Catalog No. HT0586, Lot Nos.(Work Nos.)13216, 14019, 14201, 14418, 15195, 15312, 16142, 16416, 16872. RECALLING FIRM/MANUFACTURER Recalling Firm: SRI/Surgical Express Tampa, FL, by telephone, fax and letter on Aug. 9, 2001. Manufacturer: Alliance Healthcare McGaw Park, FL. Firm initiated recall is complete. REASON Component Resuscitation Bag recalled due to improper duck bill action. VOLUME OF PRODUCT IN COMMERCE 1460 packs. DISTRIBUTION KY. _______________________ PRODUCT a) Medtronic Bio-Medicus Femoral Cannula and Introducer; 17 Fr.. b) Medtronic Bio-Medicus Femoral Cannula and Introducer; 19 Fr. Recall # Z-0467-02. CODE a) Product code 96570-017. Lot 2001070003. b) Product code 96570-019. Lot 2001070038. RECALLING FIRM/MANUFACTURER Medtronic Cardiac Surgical Products Grand Rapids, MI, by personal visit beginning on or about Oct. 15, 2001. Firm initiated recall is complete. REASON Cannula size not as labeled. VOLUME OF PRODUCT IN COMMERCE 15. DISTRIBUTION CA, CT, FL, IL, NC, OH, WA and Canada.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_________________________________________ PRODUCT 3M Tegagel Hydrogel Wound Filler, 3 oz. tube, Catalog Number 90412, Recall # Z-0432-02. CODE Lot 6104101, Expiration date 05/03. RECALLING FIRM/MANUFACTURER Recalling Firm: 3M Health Care, 3M Company St. Paul, MN, by letter dated Oct. 4, 2001. Manufacturer: Darja Laboratories, Inc. Minden, NV. Firm initiated recall is ongoing. REASON The product tubes were filled with a different brand of a similar product which has many of the same ingredients. VOLUME OF PRODUCT IN COMMERCE 5508 tubes. DISTRIBUTION Nationwide, Canada and Korea. ______________________ PRODUCT Pathromtin Reagent, Recall # Z-0434-02. CODE Catalog # OTXA25 Lot numbers 543803 exp. 2/1/02, 543804 exp. 7/26/02, and 543805 exp 1/28/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Dade Behring, Inc. Newark, DE, by letters dated Dec. 3, 2001. Manufacturer: Dade Behring Marburg GMBH Marburg. Firm initiated recall is ongoing. REASON Prolonged APTT clotting times. VOLUME OF PRODUCT IN COMMERCE 3502 units. DISTRIBUTION Nationwide _______________________ PRODUCT Immulite Tree Specific IgE; 100 test Kit Id# LKTR1 116 Not cleared for domestic distribution, Recall # Z-0436-02. CODE All Codes. RECALLING FIRM/MANUFACTURER Diagnostic Products Corp. Los Angeles, CA, by telephone and fax on October 31, 2001. Firm initiated recall is ongoing. REASON Packaging equipment failure causing missing bead component. VOLUME OF PRODUCT IN COMMERCE 8. DISTRIBUTION International _______________________ PRODUCT Immulite Total IgE; Radioimmunoassay; Packed in 100 test kit under ID#: LKIE 1 160 and in 500 test kit under ID# LKIE 5 160, Recall # Z-0438-02. CODE All lots. RECALLING FIRM/MANUFACTURER Diagnostic Products Corp. Los Angeles, CA, by telephone on October 31, 2001. Firm initiated recall is ongoing. REASON Packaging equipment failure. VOLUME OF PRODUCT IN COMMERCE 612 of both sizes 100/500. DISTRIBUTION International. _______________________ PRODUCT Ortho Development Cancellous Bone Screw Dia. 6.5mm x 35mm. Catalog No. 146-1035, Lot No. W011026, Recall # Z-0441-02. CODE Catalog Number: 146-1035, Lot No. W011026 RECALLING FIRM/MANUFACTURER Ortho Development Corp., Draper, UT, by telephone on Sept. 14, 2001. Firm initiated recall is complete. REASON 40mm Cancellous Bone Screws were labeled as 35mm. VOLUME OF PRODUCT IN COMMERCE 6 screws. DISTRIBUTION UT and Japan. _______________________ PRODUCT Bion Epstein-Barr (VCA) Antigen Substrate For IFA Test System, 12 Well Slide; Bion Enterprises, Ltd., Park Ridge, IL. The 12 Well Slides are packaged individually as product number EB-5012, and as a component of the EBV-M (VCA) Test System, product number EMB-120, with 10 slides per kit, Recall # Z-0444-02. CODE Product No. EB-5012, lot EB-0843 The slides were also packed into Product No. EBM-120, lot KEBMT-039. RECALLING FIRM/MANUFACTURER Bion Enterprises, Ltd. Des Plaines, IL, by telephone on Jan. 18 and Oct. 16 and 17, 2001. Firm initiated recall is complete. REASON The slides were difficult to read using IgM testing. VOLUME OF PRODUCT IN COMMERCE 545 slides. DISTRIBUTION IA, SC, MN, WV, TX, IL and England. _______________________ PRODUCT Calibration Solution: IL Test Cal 1 Solution (500 mL) for IL Synthesis Analyzers Models 1720 and higher. Recall # Z-0450-02. CODE Part Number: 98332-00 Lot Number: N0518679 Exp.Date: 5/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Laboratory CO. Lexington, MA, by letters on July 31, 2001. Manufacturer: Instrumentation Laboratories Orangeburg, NY. Firm initiated recall is ongoing. REASON Calibrator may cause abnormally low or high calcium and chloride QC values. VOLUME OF PRODUCT IN COMMERCE 1521 bottles. DISTRIBUTION Nationwide and Mexico; Intermedico Canada. _______________________ PRODUCT MediSense Optium Blood Glucose Test Strips for use with the MediSense Optium Blood Glucose Monitoring System [50 test strips/box]. Recall # Z-0452-02. CODE Part Number: 99134-15 Lot Numbers: 50111, 50113, and 50123 Expiration Date: 30 SEP 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Medisense Products Bedford, MA, by telephone on Oct. 5, 2001. Manufacturer: Medisense United Kingdom Limited Abingdon, United Kingdom. Firm initiated recall is ongoing. REASON Incorrectly programmed calibrator fails to calibrate the glucose meter. VOLUME OF PRODUCT IN COMMERCE 3570 boxes of 50. DISTRIBUTION FL and OH. _______________________ PRODUCT Vaxcel Implantable Access Port Mini Port, Titanium 6 F, Polyurethane Catheter. Recall # Z-0465-02. CODE Catalog Number: 45-303 Lot Number: 0699. RECALLING FIRM/MANUFACTURER Recalling Firm: Meditech a Division of Boston Scientific Corp. Watertown, MA, by letter on March 8, 2001. Manufacturer: Gerard Medical, Inc. Charlton City, MA. Firm initiated recall is ongoing. REASON Device Mislabeled as 6 French Instead of an 8 French Dilator VOLUME OF PRODUCT IN COMMERCE 59. DISTRIBUTION Nationwide _______________________ PRODUCT Industrial first aid kits consisting of cabinets filled with medical supplies including Medi First Plus Pain Relieving Burn Spray with Aloe Vera Antiseptic Anesthetic, lot 0010004, and/or Medi First Plus Pain Relieving Antiseptic Spray, lot 0003092; Recall # Z-0468-02/Z-0473-02. CODE Product code 723REST, lot 5679 and 5945 Product code 745LSC, lot 5681 Product code 756LSC, lot 5680 Product code P786GDX, lot 5802 and 6587 Product code P956DX, lot 4809, 5194, 6152, 6175 and 6185 Product code P964DX, lot 4301, 4425, 5125, 5700 and 6614. RECALLING FIRM/MANUFACTURER Textilease Medique Wood Dale, IL, by letter dated Sept. 10, 2001. Firm initiated recall is ongoing. REASON First Aid kits contain Burn Relief Spray &/or Antiseptic Spray recalled by York. Sprays are sub- and super-potent. VOLUME OF PRODUCT IN COMMERCE 2994 kits. DISTRIBUTION Nationwide. _______________________ PRODUCT First Aid Kits, Recall # Z-0474-02/Z-0484-02. CODE There are no codes applied to the various First Aid Kits affected. RECALLING FIRM/MANUFACTURER Zee Service Inc. Irvine, CA, by letter and fax on Sept. 21, 2001. Firm initiated recall is ongoing. REASON First Aid kits contain Burn Relief Spray &/or Antiseptic Spray recalled by York. Sprays are sub- and super-potent. Also, leaking containers or loose caps. VOLUME OF PRODUCT IN COMMERCE Not disclosed. 62 domestic customers. DISTRIBUTION Nationwide and to Canada.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT The following 10 animal feed products were subject to this recall: 1- Sexton Brothers MIXED FEED-WM, Recall # V-019-2 2- Sexton Brothers 9% SWEET FEED, Recall # V-020-2 3- Sexton Brothers 13% SWEET FEED, Recall # V-021-2 4- Sexton Brothers WHEAT, Recall # V-022-2 5- Sexton Brothers 44% SOYBEAN MEAL, Recall # V-023-2 6- Sexton Brothers 14% GOAT FEED, Recall # V-024-2 7- Sexton Brothers WHEAT MIDDS, Recall # V-025-2 8- Sexton Brothers SHELLED CORN, Recall # V-026-2 9- Sexton Brothers OATS, Recall # V-027-2 10-Sexton Brothers 17% GOAT FEED, Recall # V-028-2 The feed products were packaged in 50 LB bags, under the Willard Milling Company label. CODE No codes. All recalled products that were distributed prior to July 30, 2001 are affected by this recall. RECALLING FIRM/MANUFACTURER Willard Milling, Inc. Willard, KY, by letter and telephone on July 30, 2001. State initiated recall is complete. REASON Products may contain protein derived from mammalian tissues. VOLUME OF PRODUCT IN COMMERCE Approx. 140 tons DISTRIBUTION OH, KY, IN, and WV.END OF ENFORCEMENT REPORT FOR January 23, 2002 ####
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