June 26, 2002 02-25
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT WEDGWOOD TUSCANY COLLECTION GLASS BOWL, Made in Romania a) Tuscany Glass Bowl 6". Recall # F-542-2; b) Tuscany Glass Bowl 11" (salad bowl). Recall # F-543-2. CODE a) ITEM NO. 5-69103-1005*** UPC NO. 091569059110*** b) ITEM NO. 5-69103-1006*** UPC NO. 091569059127*** RECALLING FIRM/MANUFACTURER Recalling Firm: Waterford Wedgwood USA, Inc., Wall, NJ, by fax and e- mail on December 13, 2001. Manufacturer: R&G International Srl, Bucharest, Romania. Firm initiated recall is ongoing. REASON Glass bowls contain elevated levels of lead and cadmium. VOLUME OF PRODUCT IN COMMERCE 6. DISTRIBUTION Nationwide. _______________________ PRODUCT Natureís Goodness brand Chowders Soup, Potato with Broccoli and Cheese in 18.5 Oz. Cans. Recall # F-544-2. CODE All codes, including UPC code: 45370-80043. RECALLING FIRM/MANUFACTURER Recalling Firm: Innovative Closeout Systems, Fremont, CA, by telephone on February 26, 2002 and by letter on February 28, 2002. Firm initiated recall is ongoing. REASON The product contains undeclared clams. VOLUME OF PRODUCT IN COMMERCE 4,600 cases. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT Dalyvite Liquid, a Multi-vitamin Liquid packed in brown, plastic bottles, One Pint (473 mL). Product was distributed under the Hi-Tech label; Goldline label. Recall # F-541-2. CODE Lot 101624, expiration date 2/2003 Hi-Tech NDC 50383-624-16; Goldline NDC 0182-6151-40. RECALLING FIRM/MANUFACTURER Hi-Tech Pharmacal Co., Inc., Amityville, NY, by telephone and letter beginning March 7, 2002. Firm initiated recall is ongoing. REASON The product is contaminated with yeast, & complaints of swollen containers were received. VOLUME OF PRODUCT IN COMMERCE 15,413 - 1 pint bottles. DISTRIBUTION NY, CA, IL, NC, KY, OH, PA, IN, NJ and Puerto Rico.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
****CORRECTION****
Doxorubicin Hydrochloride Injection, USP, Recall # D-281-2 from Enforcement Report 02-22, June 5, 2002, had Gensia Sicor Pharmaceuticals, Inc., Irvine, CA listed as the manufacturer. The correct manufacturer: Pharmacia (Perth) Pty. Limited, Bentley WA 6102 Australia.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Tri-Nasal Nasal Spray (triamcinolone acetonide, USP) 50 mcg (0.05%), 120 metered sprays, 15mL bottles and professional samples, For Intranasal Use Only, Rx Only. Recall # D-335-2. CODE NDC 0451-5050-15 Product code: 5050-15 Retail 10605 10705 10805 11006 10807 NDC 0451-5050-00 Product code: 5050-00 Professional Samples 10406 10806 10106 10706 10906 10308 10408 10808 10708 10109 10211 10711 10112. RECALLING FIRM/MANUFACTURER Muro Pharmaceutical, Inc., Tewksbury, MA, by mail beginning the week of June 7. Firm initiated recall is ongoing. REASON Subpotent;potency of the active ingredient triamcinolone acetonide cannot be assured through labeled expiration date VOLUME OF PRODUCT IN COMMERCE 377,742. DISTRIBUTION Nationwide. _______________________ PRODUCT Tamiflu Capsules (oseltamivir phosphate),75mg, 10 capsule cartons and 15 x1 capsule Professional Samples, Rx only. Recall # D-336-2. CODE Cartons of 10 Capsules B1022-01, exp. 6/02 B1023-01, exp. 6/02 B1024-01, exp. 6/02 B1025-01, exp. 6/02 B1029, exp. 9/02 B1029-01, exp. 9/02 B1025-02, exp. 6/02 Physician Samples (15s) B1025-03, exp. 6/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Laboratories, Nutley, NJ, by letter on April 19, 2002. Manufacturer: F. Hoffmann - La Roche, AG CH-4070 Basel, Switzerland. Firm initiated recall is ongoing. REASON Potential cross contamination with active ingredients which could include mefloquine, levodopa/benserazide, and/or sulfamethoxazole. VOLUME OF PRODUCT IN COMMERCE 1,021,141 trade lots; 1,800 free goods; 153,264 physician samples. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Recovered Plasma, Recall # B-1319-2. CODE Units 1135168, 1135173, 1135178, 1135182, 1135193, 1135195, 1135198, 1135203, 1135352, 1135359, 1135801, 1135802, 1135804, 1135807, 1135810, 1135816, 1135824, 1135832, 1135837, 1136162, 1136172, 1136218, 1136222, 1136440, 1136477, 1980227, 1980241, 1980243, 1980262, 1980270, 1980299, 1980342, 1980355, 1980361, 1980365, 1980379, 1980382, 1980448, 1980461, 1980510, 1982019, 1982249, 1982260, 1982265, 1982319, 1982322, 1982338, 1982339, 1982344, 1982347, 1982348, 1982349, 1982350, 1982351, 1982352, 1982353, 1982356, 1982377, 1982381, 1982395, 1982399, 1982400, 1982401, 1982428, 1982457, 1983121, 1983123, 1983124, 1983125, 1983126, 1983127, 1983128, 1983129, 1983130, 1983131, 1983134, 1983424, 1983425, 1983439, 2110142, 2110148, 2110165, 2110174, 4536419, 4536436, 4536437, 4536439, 4536440, 4536473, 4536512, 4536689, 4536708, 4536709, 4536710, 4536738, 4536757, 4537116, 4537709, 4537731, 4537736, 4537761, 4537791, 4537795, 4537813, 4537816, 4537818, 4537824, 4537827, 4537829, 4537831, 4537832, 4537899, 4537901, 4537912, 4537915, 4537916, 7919816, 7919910, 7919929, 7919965, 7919973, 7921027, 7921042, 7921047, 7921381, 7922017, 7922023, 7922025, 7922032, 7922035, 7922036, 7922038, 7922040, 7922045, 7922057, 7922059, 7922060, 7922183, 7922407, 7922408, 7922419, 7922427, 7922484, 8756143, 8756146, 8756342, 8756343, 8756510, 8756577, 8757141, 8757186, 8757283, 8757286, 8757638, 8757852, 8757947, 8757953, 8757954, 8757955, 8757956, 8757967, 8757978, 8757981, 8757986, 8757987, 8757991, 8757998, 8758004, 8758008, 8758009, 8758011, 8758063, 8758075, 8758079, 8758080, 8758084, 8758091, 8758092, 8758094, 8758095, 8758098, 8758101, 8758104, 8758111, 8758118, 8758122, 8758131, 8758152, 8758198, 8758208, 8758240, 8758242, 8758248, 8758249, 8758252, 8758254, 8758261, 8758263, 8758264, 8758265, 8758266, 8758270. RECALLING FIRM/MANUFACTURER Nassau Health Care Corporation, Nassau University Medical Center, East Meadow, New York, by letter dated March 26, 2002. Firm initiated recall is complete. REASON Recovered Plasma units, inaccurately tested for viral markers, were distributed. VOLUME OF PRODUCT IN COMMERCE 202 units. DISTRIBUTION NJ. _______________________ PRODUCT Plasma, Frozen, Recall # B-1328-2. CODE Unit 03LH05696. RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA, by telephone on October 1, 2001 and by letter dated October 29, 2001. Firm initiated recall is complete. REASON Blood product, which was not quarantined after receiving information concerning post-donation illness, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1447-2; b) Platelets, Recall # B-1448-2; c) Plasma, Recall # B-1449-2. CODE a), b) and c) Unit 53FP10244. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated June 7, 2001. Firm initiated recall is complete. REASON Blood products, which tested negative for anti-HCV, but were collected from a donor who provided post donation information regarding previously testing positive for Hepatitis C, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MD and DC. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Irradiated, Recall # B-1450-2 b) Red Blood Cells, Recall # B-1451-2; c) Recovered Plasma, Recall # B-1452-2. CODE a) Unit 53F33376; b) and c) Units 53FM44217, 53R80459. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated April 5, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who provided post donation information regarding previously testing positive for hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MD and DC. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1456-2; b) Recovered Plasma, Recall # B-1457-2. CODE a) and b) Unit number 29GH21398. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters on April 6 and 9, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA and CA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1458-2 CODE Unit numbers H202908 #1 and H202908 #2. RECALLING FIRM/MANUFACTURER Puget Sound Blood Center and Program, Seattle, WA, by telephone on January 23, 2002. Firm initiated recall is complete. REASON Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1460-2. CODE Unit number 10711-1152 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 10, 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 AZ. _______________________ PRODUCT Source Plasma, Recall # B-1461-2 CODE Unit numbers 44971953, 44970857, 41608838, 41607664, 41603468, 41601310, 41509876, 41508367, 41506530, 41505311, 41504437, 41502082, 41501221, 41499177, 41498231, 41496374, 41495551, 41492369, 41491249, and 41730195 RECALLING FIRM/MANUFACTURER Sera-Tec Bioloigcals Limited Partnership, BioLife Plasma Services L.P., Portsmouth, VA REASON Blood products, that tested negative for viral markers, but were collected from a donor who had been previously deferred for a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 20 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1462-2; b) Recovered Plasma, Recall # B-1463-2. CODE a) and b) Unit 35J59504. RECALLING FIRM/MANUFACTURER American Red Cross, Appalachian Region, Roanoke, VA, by letter dated May 11, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor whose partner had been diagnosed with hepatitis B, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Recall # B-1478-2. CODE Unit C11736. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by telephone on April 25, 2001 and by fax on April 26, 2001 and by letter dated April 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor whose donor suitability was not properly determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA and Switzerland. ______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1482-2; b) Cryoprecipitated AHF, Recall # B-1483-2; c) Plasma, Recall # B-1484-2. CODE a); b) and c) Unit number 29FK34726. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated June 18, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WV, PA and MA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1485-2. b) Plasma, Recall # B-1486-2. CODE a) and b) Unit number 29FC64785. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone and letter on December 12, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor who had been previously deferred for a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NC and IA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1487-2; b) Recovered Plasma, Recall # B-1488-2. CODE a) and b) Unit number 29GT36725. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters on February 1 and 5, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NC and CA. _______________________ PRODUCT Red Blood Cells, Recall # B-1489-2. CODE Unit number M42488. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on March 7, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Recall # B-1490-2. CODE Unit number M71811. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter and fax on April 16 and 17, 2002. 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 reported a previous reactive test for anti-HIV, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1502-2; b) Platelets, Recall # B-1503-2. CODE a) Unit numbers 24212-6679, 24213-0652, 24213-0984, 24213-1437, 24213- 2053, 24213-2068, 24213-2071, 24213-2077, 24213-2103, 24213-2113, 24213- 2128, 24213-4133, 24213-4163, 24213-4199, and 24213-5743. b) Unit numbers 24212-3177, 24209-2001, 24209-2019, 24212-3184, and 24212-3188 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 29, 2001. Manufacturer: Blood Systems, Inc., Rapid City, SD. Firm initiated recall is complete. REASON Blood products, incorrectly tested for Cytomegalovirus (CMV), were distributed. VOLUME OF PRODUCT IN COMMERCE 20 units. DISTRIBUTION SD. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1504-2. CODE Unit numbers 10705-1038 and 10633-6532. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated July 17, 2001. 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 AZ and VA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1505-2; b) Platelets Pheresis, Recall # B-1506-2. CODE a) Unit number 10207-5649; b) Unit number 10213-3863 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 13, 2001. 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 AZ. _______________________ PRODUCT Red Blood Cells, Recall # B-1507-2. CODE Unit number F87751 (distributed as two split units). RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by telephone on January 28, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-1508-2. CODE Unit number T19545. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter and fax on April 2, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Recall # B-1509-2. CODE Unit number L08600. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter and fax on April 2, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1510-2. CODE Unit numbers 36262-7396, 36262-2397, 36262-0137, 36261-5714, 36261-2237, 36261-7018, 36260-8780, and 36260-7125 (all units distributed as 2 split units). RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on September 10, 2001 and by letter on October 5, 2001. Manufacturer: Blood Systems, Inc., Ventura, CA. Firm initiated recall is complete. REASON Platelets with an increased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 16 units. DISTRIBUTION CA. _______________________ PRODUCT Whole Blood, Recall # B-1511-2. CODE Unit numbers 1617480, 1617500, 1623005, 1623006, 1623010, 1623011, 1623012, 1623028, 1623030, 1623032, 1623054, 1623057, 1623065, 1623067, 1623073, 1623090, 1623095, 1623098, 1623109, 1623165, 1623179, 1623201, 1623214, 1623227, 1623225, 1623230, 1623231, 1623232, 1623260, 1623262, and 1623275. RECALLING FIRM/MANUFACTURER New York Blood Center, Inc., New York, NY, by letter dated April 5, 2002. Firm initiated recall is complete. REASON Blood products, manufactured from units of Whole Blood that were collected in the incorrect size collection bag, were distributed. VOLUME OF PRODUCT IN COMMERCE 31 units. DISTRIBUTION NY and MD.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Human Tissue for Transplantation of the following types: Recall # B-1243-2. Corneas; Sclera. CODE Numbers 0-96229 OD and 0-96229 OS; Numbers 0-96229 A and 0-96229 B. RECALLING FIRM/MANUFACTURER Lions Eye Bank of Nebraska, Inc., Omaha, NE, by telephone on May 8 and 10, 2002 and by letter dated May 13, 2002. Firm initiated recall is complete. REASON Human tissue for transplantation was distributed from a donor that tested repeatedly reactive for human immunodeficiency virus (HIV) by the p24 antigen assay. VOLUME OF PRODUCT IN COMMERCE 4 tissues. DISTRIBUTION NE and FL. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1258-2. CODE Unit 10610-7666. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 11, 2002 and by letter dated February 6, 2002. Manufacturer: United Blood Services, Scottsdale, AZ. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1261-2. CODE Unit 35Z11334. RECALLING FIRM/MANUFACTURER American Red Cross, Appalachian Region, Roanoke, VA, by telephone on August 22, 2001. Firm initiated recall is complete. REASON Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Source Plasma, Recall # B-1326-2. CODE Unit G-54611-009. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, City of Industry, CA, by fax dated March 13, 2001. Firm initiated recall is complete. REASON Source Plasma, that tested negative for hepatitis C, but was collected from a donor that subsequently tested reactive for hepatitis C, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION The United Kingdom _______________________ PRODUCT Whole Blood, For Manufacturing Use Only, Recall # B-1387-2. CODE Units 0726996, 0747852, 0748642, 0750525, 0755505, 0763862, 0764877 RECALLING FIRM/MANUFACTURER Memorial Blood Center, Minneapolis, MN, by letter on September 18, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor whose health history screening was not adequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION PA and GA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1388-2. CODE Unit number 1611312. RECALLING FIRM/MANUFACTURER Inland Northwest Blood Center, Spokane, WA, by letter dated October 17, 2001. Firm initiated recall is complete. REASON Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WA. _______________________ PRODUCT Reagent Red Blood Cells of the following types: a) Panel One, Recall # B-1417-2; b) Ficin Panel One, Recall # B-1418-2. CODE a) and b) Lot number 0724446 RECALLING FIRM/MANUFACTURER Recalling Firm: Immucor, Inc., Norcross, GA, by letter dated August 8, 2001. Manufacturer: Gamma Biologicals, Inc., Houston, TX. Firm initiated recall is complete. REASON Reagent Red Blood Cells, incorrectly labeled as V antigen positive, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 lots. DISTRIBUTION Nationwide and Internatinally. _______________________ PRODUCT Red Blood Cells, Recall # B-1423-2. CODE Unit W15789. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by telephone and letter on August 21, 2001. Firm initiated recall is complete. REASON Blood product, which was determined to have a high hematocrit value, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1476-2; b) Fresh Frozen Plasma, Recall # B-1477-2. CODE a) and b) Unit FH93986. RECALLING FIRM/MANUFACTURER Southern California Permanente Medical Group Blood Bank, San Diego, CA, by fax on October 25, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who was using Metrogel antibiotic, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Recovered Plasma, Recall # B-1479-2. CODE Unit C11736. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by telephone on April 25, 2001 and by fax on April 26, 2001 and by letter dated April 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor whose donor suitability was not properly determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA and Switzerland. _______________________ PRODUCT a) Pneumovax? 23 (Pneumococcal Vaccine Polyvalent). Product numbers - 04829 and 04741. Recall # B-1480-2; b) Recombivax HB(r) (Hepatitis B Vaccine Recombiant). Product number - 04769; Recall # B-1481-2. CODE a) Lot numbers: 1818K exp. 10/12/02, 0385L exp. 10/12/02, and 0102L exp. 10/12/02; b) Lot numbers: 1849K exp. 12/7/03. RECALLING FIRM/MANUFACTURER Merck Manufacturing Division, Division of Merck and Co., Inc., West Point, PA, by telephone, personal visits and letters dated October 19, 24, 25, 26, 29, 30 and November 6, 2001. Firm initiated recall is complete. REASON Vaccines, manufactured with negative air flow to the filling room during processing, were distributed. VOLUME OF PRODUCT IN COMMERCE a) Lot numbers: 1818K exp. 10/12/02 (8,189 units), 0385L exp. 10/12/02 (100,275 units), and 0102L exp. 10/12/02 (91,947 units) b) Lot numbers: 1849K exp. 12/7/03 (101,095 units). DISTRIBUTION Internationally. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1491-2; b) Platelets Irradiated, Recall # B-1492-2. CODE a) and b) Unit number M42134. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on February 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm inspection was noted to be unacceptable, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1498-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1499-2; c) Cryoprecipitated, Recall # B-1500-2; d) Recovered Plasma, Recall # B-1501-2 CODE a) Unit number 38FM41309; b) Unit numbers 38H63090, 38H63091, 38H63092, 38H63093, 38H63094, 38H63095, 38H63096, 38H63097, 38H63098, 38H63099, 38H63100, 38H63101, 38H63102, 38FM41304, 38FM41305, 38FM41306, 38FM41307, 38FM41308, 38FM41310, 38FM41311, 38FM41312, 38FM41313, 38FM41314, 38FM41315, 38FM41316, 38FM41317, 38FM41318, and 38FM41319 c) Unit numbers 38H63090, 38H63091, 38H63092, 38H63093, 38H63094, 38H63095, 38H63096, 38H63097, 38H63098, 38H63099, 38H63100, 38H63101, and 38H63102 d) Unit numbers 38H63090, 38H63091, 38H63092, 38H63093, 38H63094, 38H63095, 38H63096, 38H63097, 38H63098, 38H63099, 38H63100, 38H63101, 38H63102, 38FM41304, 38FM41305, 38FM41306, 38FM41307, 38FM41308, 38FM41309, 38FM41310, 38FM41311, 38FM41312, 38FM41313, 38FM41314, 38FM41315, 38FM41316, 38FM41317, 38FM41318, and 38FM41319. RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letters and fax on November 13 and 14, 2001. Firm initiated recall is complete. REASON Blood products, manufactured from units of Whole Blood whose shipping temperature was measured with a thermometer that was found to fail calibration testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 71 units. DISTRIBUTION IN, Puerto Rico, CA and Switzerland. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1513-2. CODE Unit number 40GL88448. RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on April 29, 2002 and by letter dated May 13, 2002. Firm initiated recall is complete. REASON Blood product possibly exposed to unacceptable shipping temperatures was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2. CODE Serial Numbers: B1552349 C1572413 C1572414 C1572415 C1572417 C1572418 C1572420 C1572423 C1572428 C1572429 C1572430 C1572431 C1572432 C1572433 C1572421. RECALLING FIRM/MANUFACTURER Toshiba America Medical Systems, Inc., Tustin, CA, by letters dated February 22, 2002. Firm initiated recall is ongoing. REASON Software anomally caused error in calculating VM_P. VOLUME OF PRODUCT IN COMMERCE 15. DISTRIBUTION CA, ID, LA, MA, MD, MS, MT, OR and TX. ____________________ PRODUCT Puritan Bennett-840 Ventilator System with optional compressor. Recall # Z-1040-2. CODE Ventilators with Rev. E BD CPU boards with Serial numbers 3510000007 through 3510012304. RECALLING FIRM/MANUFACTURER Recalling Firm: Tyco Healthcare, Nellcor Puritan Bennett, Pelasanton, CA, by letter dated October 22, 2001. Manufacturer: Nellcor Puritan Bennett, Ireland, Ltd. Mervue, Galway, Ireland. Firm initiated recall is ongoing. REASON Failure of optional compressor on ventilator. VOLUME OF PRODUCT IN COMMERCE 2,599 ventilators systems and 299 field replacement units with Rev. E BD CPU boards. DISTRIBUTION Nationwide and Internationally.END OF ENFORCEMENT REPORT FOR JUNE 26, 2002 ####
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2002-JUN-27.