The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
June 12, 2002 02-23
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT The following 4 products are recalled: a) Romanoff Black Lumpfish Caviar, pasteurized in 7 oz. glass jars, 6 per case, Product/Item #23004. Recall # F-471-2; b) Romanoff Fresh Black Lumpfish Caviar, Refrigerated in 20 LB. plastic pails, 1 per case, Prduct/Item #23038. Recall # F-472-2; c) Romanoff Whitefish Caviar, pasteurized in 15 oz. glass jars, 6 per case, Product/Item #24922. Recall # F-473-2; d) Romanoff Fresh Red Lumpfish Caviar, Refrigerated in 20 LB. plastic pail, 1 per case, Product/Item #24908. Recall # F-474-2. CODE All codes. RECALLING FIRM/MANUFACTURER Recalling Firm: T. Marzetti Co., Columbus, OH, by telephone on March 2, 2002 and by letter on March 5, 2002. Manufacturer: Quality Bakery, Columbus, OH. FDA initiated recall is complete. REASON Black lumpfish caviar and whitefish caviar contain undeclared FD&C colors Red #40 and Blue #1. Red Lumpfish Caviar contains undeclared FD&C Red #40. VOLUME OF PRODUCT IN COMMERCE 612 cases (3,372 containers). DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Heparin Sodium Injection, USP, DERIVED FROM PORCINE INTESTINES, 1000 units/mL, 1 mL DOSETTE Vials, 10 mL and 30 mL Multiple Dose Vials, IV or SC use, Rx only. Recall # D-285-2. Packaged as: 25 x 1 mL DOSETTE Vials, 25 x 10 mL Multiple Dose Vials, and 25 x 30 mL Multiple Dose Vials. CODE All Lots. RECALLING FIRM/MANUFACTURER Wyeth Ayerst/Elkin Sinn Cherry Hill, NJ, by letter on April 29, 2002. Firm initiated recall is ongoing. REASON Particulates; clear crystals containing an antioxidant compound from the vial rubber closures (stoppers). VOLUME OF PRODUCT IN COMMERCE 0641-0391-25 -- 108,291 vials; 0641-2440-45 -- 612,058 vials; 0641-2450-45 -- 1,168,878 vials. DISTRIBUTION Nationwide and Costa Rica. _______________________ PRODUCT Lomotil tablets, Each tablet contains: diphenoxylate hydrochloride, USP 2.5 mg atropine sulfate USP 0.025 mg, Rx only, bottles of 100, 1,000, 2,500, and unit dose cartons of 100. Recall # D-286-2. CODE Lot Numbers C200511 and C200682 in 100 tablet bottles; Lot Numbers C200195 and C200577 in 1,000 tablet bottles; Lot Number C200363 in 2,500 tablet bottles; Lot Number C200360 in 100 tablet unit dose carton. RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmacia Corp., Kalamazoo, MI, by letters dated May 29, 2002. Firm initiated recall is ongoing. REASON Tablets may contain metal particles. VOLUME OF PRODUCT IN COMMERCE 9,720 bottles and cartons. DISTRIBUTION Nationwide. _______________________ PRODUCT Levoxyl Tablets, 50 mcg, Each tablet contains Levothyroxine Sodium 50 mcg, 100 tablet bottles, Rx only. Recall # D-287-2; Levoxyl Tablets, 100 mcg, Each tablet contains Levothyroxine Sodium 100 mcg, 30 and 100 tablet bottles, Rx only, Recall # D-288-2. CODE 100 mcg, 30 tablet bottles 1243074, 1249173, 1250073, 1270231, 1275251, 1283185, 1297190 Product code 5297-0; 100 mcg, 100 tablet bottles 1229122, 1234214, 1243125, 1253084, 1274147 Product code 5297-1; 50 mcg, 100 tablet bottles 1270232, 1274149, 1275252, 1278114, 1282197 Product code 5300-0. RECALLING FIRM/MANUFACTURER Recalling Firm: Allscripts Healthcare Solutions, Libertyville, IL, by letter dated May 22, 2002. Manufacturer: King Pharmaceuticals, Inc. (formerly Daniels Pharmaceuticals), St. Petersburg, FL. Firm initiated recall is ongoing. REASON Product from manufacturer lacks stability prior to expiration date (subpotency and super potency). VOLUME OF PRODUCT IN COMMERCE 13,820 - 100 mcg tablets, 18,600 - 50 mcg tablets. DISTRIBUTION Nationwide. _______________________ PRODUCT Oxygen USP, compressed, held in high pressure cylinders. Recall # D-329-2. CODE Lot code: 010481/4. RECALLING FIRM/MANUFACTURER Southern Welding Supply Co., Inc., Savannah, GA, by personal visit on March 26, 2002. Firm initiated recall is complete. REASON Good Manufacturing Practice (GMP's) Deviations including, but not limited to, failure to test for purity and identity. VOLUME OF PRODUCT IN COMMERCE 37. DISTRIBUTION GA.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Premarin Tablets (conjugated estrogens tablets, USP) 0.625 mg, Rx Only. Recall # D-216-2. Bottles of 100 - NDC #0046-0867-81 Bottles of 1000 - NDC #0046-0867-91 Bottles of 5000 - NDC #0046-0867-95. CODE Lot Numbers: 9001566, exp. 07/03 9010254, exp. 07/03 9010255, exp. 07/03 EXPANDED RECALL: 9010509, exp. 10/03 9010510, exp. 10/03. RECALLING FIRM/MANUFACTURER Recalling Firm: Wyeth-Ayerst Laboratories, Richmond, VA, by letters dated February 21, 2002. Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY. Firm initiated recall is ongoing. REASON Failure to meet dissolution specifications. VOLUME OF PRODUCT IN COMMERCE 47,024 btls of 100; 9,255 btls of 1000; and 1,408 btls of 5000. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Recall # B-1212-2. CODE Unit C81380. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letter dated March 7, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor whose Hemoglobin level was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Red Blood Cells, Recall # B-1213-2. CODE Unit C51957. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letter dated February 22, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor whose hemoglobin level was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1214-2. CODE Unit 07FJ60559. RECALLING FIRM/MANUFACTURER American Red Cross, Arizona Region, Tucson, AZ, by letter dated November 27, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who lived in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1215-2; b) Platelets, Recall # B-1216-2. CODE a) and b) Unit C64932. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letters dated February 15, 2002. 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 IL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1217-2 b) Platelets, Recall # B-1218-2. CODE a) and b) Unit C56373. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letters dated February 27, 2002. 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 IL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1221-2; b) Platelets, Recall # B-1222-2. c) Recovered Plasma, Recall # B-1223-2. CODE a), b) and c) Units H53631, H74401. RECALLING FIRM/MANUFACTURER Regional Health Resource Center, Community Blood Services of IL, Urbana, IL, by telephone on January 8 and 9, 2002 and by letter dated January 31, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who had engaged in high risk behavior, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION IL, TX and CA. _______________________ PRODUCT Platelets Pheresis, Leukoycytes Reduced, Recall # B-1224-2. CODE Unit J17098. RECALLING FIRM/MANUFACTURER Recalling Firm: Regional Health Resource Center, Community Blood Services of IL, Urbana, IL, by telephone on February 14, 2002 and by letter dated April 18, 2002. Firm initiated recall is complete. REASON Blood product, collected in an unsuitable manner, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1225-2. CODE Units BTHDGR, BTHDQW, BTHFPH, BTHXSM, BTHYQK, BTJZBR, BTHZYV, BTJBKY, BTJCDN, BTJCRP, BTHHYK. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by fax dated February 21, 2002 and e-mail dated April 10, 2002. Manufacturer: Aventis Bio-Services, Inc., Dayton, OH. Firm initiated recall is complete. REASON Blood products, collected from a donor who engaged in high risk behavior, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT Red Blood Cells, Recall # B-1242-2. CODE Unit T35600. RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI, by fax on November 13, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of jaundice, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1244-2. b) Recovered Plasma, Recall # B-1245-2. CODE a) and b)Unit Z72725. RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by letter dated January 30, 2002. Firm initiated recall is complete. REASON Blood products, drawn from an unsuitable donor who immigrated from a HIV group O high risk country, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1246-2. CODE Unit KK36497. RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by letter dated December 20, 2001. Firm initiated recall is complete. REASON Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Platelets, Pheresis, Recall # B-1252-2. CODE Unit K16090. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by telephone on May 16, 2000. Firm initiated recall is complete. REASON Platelets, with a decreased platelet count, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Washington DC. _______________________ PRODUCT Recovered Plasma, Recall # B-1281-2. CODE Unit C84706. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL by fax dated February 20, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1284-2; b) Recovered Plasma, Recall # B-1285-2. CODE a) and b) Unit H96231. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letters dated March 19 and 22, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who had ear piercing and/or a tattoo applied within the past 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL and CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1324-2. CODE Unit 12FW02534. RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC, by letter dated January 30, 2002. Firm initiated recall is complete. 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 NC. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-1327-2. CODE Unit 12FR75270. RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC, by telephone on January 23, 2002 and by letter dated January 30, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor who had sexual contact with an individual who lived in an HIV Group O risk area, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Irradiated; b) Recovered Plasma. Recall # B-1383-2. CODE a) and b) Unit LE95198. RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by letter dated December 19, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who was taking Selegiline at the time of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1384-2. CODE Units 24213-1697, 24213-1835, 24213-1846, 24213-1858 24213-1859, 24213-2376, 24213-2418, 24213-2426 24213-2704, 24213-2714, 24213-2716, 24213-2819 24213-2831, 24213-2850. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 12 and 24, 2001. Manufacturer: United Blood Services, Rapid City, SD. Firm initiated recall is complete. REASON Blood products, collected from a donor whose hematocrit was unacceptable, were distributed. VOLUME OF PRODUCT IN COMMERCE 14 units. DISTRIBUTION SD, NE and WY. _______________________ PRODUCT a) Platelet, Pheresis, Leukoreduced, Recall # B-1389-2; b) Platelet, Pheresis, Leukoreduced, Irradiated, Recall # B-1390-2. CODE a) and b) Unit 01LZ25353. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter dated October 24, 2001. Firm initiated recall is complete. REASON Blood products, labeled as leukoreduced but did not have white blood cell count determination, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1391-2. CODE Unit 53GQ91761. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated December 28, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1392-2. CODE Unit 10GQ59958. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letters dated November 12 and December 27, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported having traveled to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Leukored, Recall # B-1393-2. CODE Unit 29GX51501. RECALLING FIRM/MANUFACTURER American Red Cross, Mid-Atlantic Region Blood Services, Norfolk, VA, by letter dated May 4, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1394-2. CODE Unit number 01P50705 RECALLING FIRM/MANUFACTURER The American National Red Cross, New York-Penn Region, West Henrietta, NY, by telephone on October 18, 2001. Firm initiated recall is complete. REASON Blood product, corresponding to a unit of Platelets that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, was distributed. VOLUME OFPRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT Source Plasma, Recall # B-1395-2. CODE Unit number 06245696. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ, by letter on August 4, 1999. Manufacturer: Sera-Tec Biologicals Limited Partnership, BioLife Plasma Services L.P., Bloomington, IN. Firm initiated recall is complete. REASON Blood product, untested for viral markers, was distributed. VOLUME OFPRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1396-2; b) Platelets, Recall # B-1397-2. CODE a) and b) Unit number 11GM31169. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on May 26, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MO and GA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1398-2; b) Fresh Frozen Plasma, Recall # B-1399-2; c) Recovered Plasma, Recall # B-1400-2. CODE a) Unit numbers 011FE16775 and 011FN34049; b) Unit number 011FN34049; c) Unit number 011FE16775. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on November 18, 1999. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an unsuitable donor based on previous reactive hepatitis testing, were distributed. VOLUME OFPRODUCT IN COMMERCE 4 units. DISTRIBUTION MO, CA, IL and OH. _______________________ PRODUCT Recovered Plasma, Recall # B-1401-2. CODE Unit numbers 11LC56048, 11LC53894, and 11LC51489. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on January 4, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed. VOLUME OFPRODUCT IN COMMERCE 3 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1402-2; b) Recovered Plasma, Recall # B-1403-2. CODE a) Unit numbers 11GH18689 and 11GH20883; b) Unit number 11GH18689. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on June 7, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for human immunodeficiency virus (HIV), but were collected from an ineligible donor based on behavior known to increase the risk of infection with HIV, were distributed. VOLUME OFPRODUCT IN COMMERCE 2 units. DISTRIBUTION GA, CA and PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1407-2; b) Fresh Frozen Plasma, Recall # B-1408-2. CODE a) and b) Unit number 11GQ06728. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on October 25, 1999. Firm initiated recall is ongoing. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. VOLUME OFPRODUCT IN COMMERCE 2 units. DISTRIBUTION MO. _______________________ PRODUCT Red Blood Cells, Recall # B-1424-2. CODE Unit numbers 017FS10395; and the following units were distributed as two split units: 017FS08916, 017FS10394, and 017FS10414. RECALLING FIRM/MANUFACTURER The American National Red Cross, North Central Region, St. Paul, MN, by telephone on July 12 and 17, 2001 and by letter dated September 5, 2001. Firm initiated recall is complete. REASON Blood products, collected using automated equipment that had not been validated, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION MN. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1425-2. CODE Unit numbers 38J46073, 38J46074, 38J46075, 38J46077, 38J46078, 38J46082, 38J46083, 38J46084, 38J46085, 38J46086, 38J46087, 38J46089, 38J46090, 38J46092, 38J46095 and 38J46091. RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on February 26, 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 16 units. DISTRIBUTION IN, MA and OH. _______________________ PRODUCT a) Platelets, Recall # B-1426-2; b) Fresh Frozen Plasma, Recall # B-1427-2. CODE a) and b) Unit number 53FN80783. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated January 3, 2002. Firm initiated recall is complete. REASON Blood products, corresponding to a unit of Red Blood Cells that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed. VOLUME OFPRODUCT IN COMMERCE 2 units. DISTRIBUTION MD and WA. _______________________ PRODUCT Red Blood Cells, Recall # B-1428-2. CODE Unit number 53GQ88331. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on July 2, 2001. Firm initiated recall is complete. REASON Blood product, collected in a manner that may have compromised the sterility of the PRODUCT, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Washington DC. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1429-2; b) Platelets, Recall # B-1430-2; c) Cryoprecipitated AHF, Recall # B-1431-2; d) Fresh Frozen Plasma, Recall # B-1432-2; e) Recovered Plasma, Recall # B-1433-2. CODE a) Unit numbers 11Z81153 and 11J37781; b) Unit numbers 11G24149 and 11J37781; c) Unit number 11J37781; e) Unit numbers 11Z81153 and 11R61541; d) Unit numbers 11J37781 and 11H54331. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on August 25, 2000. 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 symptoms or risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION MI, MO and Switzerland. _______________________ PRODUCT Platelets Pheresis, Recall # B-1434-2. CODE Unit numbers LS20828, LS20830, LS20831, LS20834, LS20835, LS20846, LS20848, LS20849, LS20851, LS20858, LS20861, LS20863, and LS20865; the following units were distributed as two split units: LS20829, LS20836, LS20840, LS20844, LS20847, LS20850, LS20854, LS20857, LS20862, and LS20864. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on August 2, 2000. Firm initiated recall is complete. REASON Blood products, collected in bags that have loose or missing tabs that cover the sterile ports, were distributed. VOLUME OFPRODUCT IN COMMERCE 33 units. DISTRIBUTION MO, AL, AK, TN and IL. _______________________ PRODUCT Red Blood Cells, Recall # B-1435-2. CODE Unit number 29GW31860. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter on February 27, 2001. Firm initiated recall is complete. REASON Blood PRODUCT, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Recall # B-1436-2. CODE Unit number FT73681. RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on July 18, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1437-2. CODE Unit numbers 10710-5337, 10708-8486, and 10703-0772. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by letter on August 16, 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 3 units. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells, Recall # B-1438-2. CODE Unit numbers C05790 and C04195. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by telephone on May 4, 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 VA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1439-2; b) Platelets Irradiated, Recall # B-1440-2. CODE a) and b) Unit number T86913. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letters dated July 2, 2001 and July 7, 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 VA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1441-2; b) Platelets, Recall # B-1442-2; CODE a) and b) Unit number 53G44476. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated May 11, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MD and Washington, DC. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1443-2. CODE Unit number 53FM47934. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated May 4, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. PRODUCT 1 unit. DISTRIBUTION MD. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1444-2. CODE Unit number 53FR79840. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated February 18, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1445-2. CODE Unit number 53V00157. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated June 19, 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 MD.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1219-2; CODE Units E10742, E31963. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letter dated March 22, 2002. Firm initiated recall is complete. REASON Blood products, which may have been stored at an unacceptable temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1220-2. CODE Unit 10725-8944. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on February 26, 2002. Manufacturer: United Blood Services, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood product, which may have been stored at an unacceptable temperature, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Platelets, Recall # B-1241-2. CODE Unit 22KW29728. RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on August 15, 2000 and by letter on August 18, 2000. Firm initiated recall is complete. REASON Blood product, prepared from a unit of Whole Blood with an extended collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1247-2; b) Platelets, Recall # B-1248-2; c) Fresh Frozen Plasma, Recall # B-1249-2; d) Cryoprecipitated AHF, Recall # B-1250-2; e) Recovered Plasma, Recall # B-1251-2. CODE a) Units G64234, G60225, G57914; b) Units G64234, G60225; c) Unit G64234; d) Unit G57914; e) Units G60225, G57914. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by fax on May 16, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Propecia, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION IA, TN, MO, IL and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1253-2; b) Fresh Frozen Plasma, Recall # B-1254-2. CODE a) and b) Unit LF020407. RECALLING FIRM/MANUFACTURER Gateway Community Blood Program, Inc., St. Louis, MO, by telephone on March 13, 2001 and letter dated March 19, 2001. Firm initiated recall is complete. REASON Blood products, that had a positive screening test for syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL and MO. _______________________ PRODUCT Red Blood Cells, Recall # B-1255-2. CODE Units L26564, T12332, T12347. RECALLING FIRM/MANUFACTURER Penn State, Milton S. Hershey Medical Center, Hershey, PA, by letter dated October 26, 2001. Firm initiated recall is complete. REASON Blood products, incorrectly tested for HIV-1 p24 antigen, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION PA. _______________________ PRODUCT a) Panel One, Recall # B-1321-2; b) Ficin Panel One, Recall # B-1322-2. CODE a) and b) Lot 1127695. RECALLING FIRM/MANUFACTURER Gamma Biologicals, Inc., Houston, TX, by letter dated December 21, 2001. Firm initiated recall is complete. REASON Reagent red blood cells, in which vials # 3 and # 7 contained the same phenotype, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 lots. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT a) Panel Two, Recall # B-1409-2; b) Ficin Panel Two, Recall # B-1410-2; c) Panel Fifteen, Recall # B-1411-2; d) Reverse Group 2, Recall # B-1412-2; e) Reverse Group 3, Recall # B-1413-2; f) Reverse Group 4, Recall # B-1414-2. CODE a) and b) Lot number 0731457; c) Lot number 0731479; d), e) and f) Lot number 0731458. RECALLING FIRM/MANUFACTURER Recalling Firm: Immucor, Inc., Norcross, GA, by letter dated August 7, 2001. Manufacturer: Gamma Biologicals, Inc., Houston, TX. Firm initiated recall is complete. REASON Reagent Red Blood Cells, that were contaminated with microorganisms, were distributed. VOLUME OF PRODUCT IN COMMERCE 3, 555 lots. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT a) Panel One, Recall # B-1415-2; b) Ficin Panel One, Recall # B-1416-2. CODE a) and b) Lot number 1211710. RECALLING FIRM/MANUFACTURER Gamma Biologicals, Inc., Houston, TX, by letter dated December 21, 2001. Firm initiated recall complete. REASON Reagent red blood cells, which were not tested for the VS antigen, but were incorrectly labeled as VS antigen negative, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 lots. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
****CORRECTION**** Recall # Z-1030-2 originally published in Enforcement Report 02-19 had an incorrect recalling firm and notification date listed. It was listed as Gambro Healthcare on April 9, 2000. The correct firm is Gambro Renal products on April 9, 2002. _______________________ PRODUCT Hematocrit and creatinine tests, as part of the i-STAT in-vitro diagnostic test system. Field Correction affected cartridges: i-STAT 6+, E3+, EC4+, EC6+, EC8+. Recall cartridges: Crea. Recall # Z-1083-2/Z-1087-2. CODE Lot Cartridge Number Total CREA R01331 9150 CREA R01318 7800 CREA R01327 7450 CREA R01305 5725 CREA R01349B 4500 CREA R01349 2575 CREA R01310 1750 CREA R01349A 1700 CREA R01355 1475 CREA R01310A 1075. RECALLING FIRM/MANUFACTURER I-Stat Corp., East Windsor, NJ, by letter dated April 22, 2002. Firm initiated recall is ongoing. REASON Erroneously high hematocrit results generated with cartridges. VOLUME OF PRODUCT IN COMMERCE 43,200 crea cartridges. DISTRIBUTION Nationwide. _______________________ PRODUCT Clearview HCG II Pregnancy Test, Recall # Z-1089-2. CODE Lot No. 4357, exp. 8/14/2002 4359, exp. 8/11/2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Medpointe, Inc. (Wampole Laboratories Division), Cranbury, NJ, by fax on March 15, 2002. Manufacturer: Unipath Ltd., Bedford, the United Kingdom. Firm initiated recall is ongoing. REASON Sensitivity deterioration of pouched PRODUCT. VOLUME OF PRODUCT IN COMMERCE Lot 4357 -- 448 kits; Lot 4359 -- 1,672 kits. DISTRIBUTION Nationwide. _______________________ PRODUCT Mitek Clearfix Meniscal Screw, 2 mm x 10 mm. Recall # B-1090-2. CODE Catalog Number: 253101 Lot Numbers: 011097, 0111229, 0111337, 0112145, 0112291. RECALLING FIRM/MANUFACTURER Mitek products, Norwood, MA, by letter between January 17 and 18, 2002. Firm initiated recall is complete. REASON Meniscal screw may be out of specification and not deploy properly. VOLUME OF PRODUCT IN COMMERCE 698. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Brand name: Uropump Tube, Uropump Damping Chamber. Recall # Z-1091-2/Z-1096-2. The tube and chamber are sold stand-alone and in four kits, the Uropump Starter Kit, the Cavernosometry Starter Kit, and two different configurations of the Instrument Set Up Kit. When sold stand alone, the UPT is sold in a box of 50, and the UPDCC in a box of 25. CODE UPDCC Lot numbers: 2835603 through 2836509; 2900101 through 2936509; 2A00101 through 2A36509; 2B00101 through 2B36103. UPT Lot numbers: 2A27002 through 2A36502; 2B00101 through 2B34401. RECALLING FIRM/MANUFACTURER Life-Tech Intl., Inc., Stafford, TX, by letter dated February 25, 2002. Firm initiated recall is ongoing. REASON Device may not be sterile. VOLUME OF PRODUCT IN COMMERCE 11,500 boxes. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Hill-Rom brand Affinity Three birthing bed. Recall # Z-1097-2. CODE All models distributed prior to March 1, 2002. RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN, by urgent recall correction notification n April 24, 2002. Firm initiated recall is ongoing. REASON Bed may change position on its own. VOLUME OF PRODUCT IN COMMERCE 1,927. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT HEARTPORT Brand Arterial Cannulas described as follows: Endo Return, 21 Fr. Endo Return, 23 Fr. Direct Flow, 24 Fr. StraightShot, Angled, 23 Fr. Arterial, 19 Fr. Recall # Z-1098-2/Z-1102-2. The above products are distributed separately as well as in the following Kit Model Numbers: EAVR23A1 ECPB212 ECPB233 ECPBA214 ED241 EAVR-23-A EAVR-23-S ED-KIT EAVR23A2 ECPB213 ECPB234 ECPBA231 ED242 SS-23-A SS-23-S SC-24 EAVR23S1 ECPB214 ECPBA211 ECPBA232 ED243 ECPB-AR21 ECPB-AR23 ED-24 EAVR23S2 ECPB231 ECPBA212 ECPBA233 ED244 ECPB-A21 ECPB-A23 ECPB211 ECPB232 ECPBA213 ECPBA234 SC24 ECPB-KIT ECPB-AR-19. CODE ER21 (07043) for Endo Return, 21 Fr. ER23 (07044) for Endo Return, 23 Fr. DFK24 (06723) for Direct Flow, 24 Fr. SS23A (06725) for StraightShot, Angled, 23 Fr. AC19 (04000) for Arterial, 19 Fr. SCK (06724) for Soft Clamp, 24 Fr. SS23S (06726) for StraightShot, Straight, 23 Fr. RECALLING FIRM/MANUFACTURER Heartport, Inc., Redwood City, CA, by letters on April 26, 2002. Firm initiated recall is ongoing. REASON A lap joint in certain arterial cannulas can separate. VOLUME OF PRODUCT IN COMMERCE 1,800 units. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT a) Monotube Triax Carbon Tube 15x200mm, Yellow, used for the stabilization of open and/or unstable fractures. Recall # Z-0769-2; b) Monotube Triax Carbon Tube 15x150mm, Yellow. Recall # Z-0770-2. CODE a) Catalog No. 5150-2-381, Lot J326229 b) Catalog No. 5150-2-371, Lot J326228. RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics, Corp., Rutherford, NJ, by letter on February 20, 2002. Manufacturer: Stryker Trauma SA, Geneva, Switzerland. Firm initiated recall is complete. REASON 200mm monotube length package actually contains a 150mm length monotube. VOLUME OF PRODUCT IN COMMERCE a) 4 ea; b) 2 ea. DISTRIBUTION NJ. _______________________ PRODUCT VITROS Immunodiagnostics. Recall # Z-1088-2. Free T3 Reagent Packs For in vitro diagnostic use. 100 test units per pack. CAT 131 5589 Responsible firm on the label: Ortho-Clinical Diagnostics, Amersham, the United Kingdom. CODE Lot numbers: 1) 500, Exp. 10 April 2002 2) 511, Exp. 22 May 2002 3) 512, Exp. 9 August 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letters on April 18, 2002. Manufacturer: Ortho-Clinical Diagnostics, Inc., Cardiff, Wales, the United Kingdom. Firm initiated recall is ongoing. REASON Failure to include Supplemental Info. Sheet that contains updated values for Free Thyroid Control lots 60, 70 & 80. VOLUME OF PRODUCT IN COMMERCE 262 domestic; and 1,981 international. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT UNLABELED hog feed in 100 lb. bags containing assorted grains (primarily corn), and Miller's Hog Supplement 36% protein. UNLABELED dairy feed in 100 lb. bags, contains assorted grains (primarily corn), soybeans and molasses. Recall # V-142-2. CODE Not CODEd. RECALLING FIRM/MANUFACTURER Recalling Firm: R. B. Crowell & Sons/Thompson Grain, Inc., Manchester, NY, by telephone on May 7 and 8, 2002. Manufacturer: John R. Power, Palmyra, NY. State initiated recall is complete. REASON Unlabeled animal feeds/possible cross contamination. VOLUME OF PRODUCT IN COMMERCE .75 tons per month. DISTRIBUTION NY. _______________________ PRODUCT Cereal Food Fines - Bulk PRODUCT. Recall # V-145-2. CODE All PRODUCT prior to October 2, 2001. RECALLING FIRM/MANUFACTURER Souder Feed & Grain Carlisle, PA, by letters dated October 9, 2001. State initiated recall is ongoing. REASON PRODUCT doesn't bear caution statement - do not feed to cattle or other ruminants. VOLUME OF PRODUCT IN COMMERCE 6,141 tons. DISTRIBUTION MO, NY and PA.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III
_______________________ PRODUCT a) Consolidated Nutrition brand Metabalance 15/25 medicated feed for starting pigs. Feed 10484AYB b) Consolidated Nutrition brand Metabalance 25/45 medicated feed for starting pigs. Feed 10485AYB. Recall # V-143-2. CODE a) Consolidated Nutrition brand Metabalance 15/25 medicated feed for starting pigs. Feed 10484AYB b) Consolidated Nutrition brand Metabalance 25/45 medicated feed for starting pigs. Feed 10485AYB RECALLING FIRM/MANUFACTURER Recalling Firm: ADM Alliance Nutrition, Inc., Quincy, IL, by telephone on February 28, 2002. Manufacturer: ADM Alliance Nutrition, Inc., Hagerstown, IN. Firm initiated recall is complete. REASON Superpotent. VOLUME OF PRODUCT IN COMMERCE 307/50 lb. bags. DISTRIBUTION IN and OH.
END OF ENFORCEMENT REPORT FOR JUNE 12, 2002
####
Office of Public Affairs
Hypertext uploaded by clb
2002-JUN-13.