June 5, 2002 02-22
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Ham and cheese sandwich in 7.25 oz. rigid plastic sandwich wedge cups manufactured on 04/09/02 with brand name "Northwest Market Fresh". The label states in part "Dist. by Inderbitzin, Tacoma, WA". Recall # F-458-2. CODE Use Before 05/07/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Stovers Kitchens, Inc., Seattle, WA, by telephone and fax on April 22, 2002 and press release on April 26, 2002. State initiated recall is complete. REASON The product was contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 254 sandwiches. DISTRIBUTION WA and OR. _______________________ PRODUCT Four flavors of white chocolate covered pretzels, each flavor in its own cello bag with affixed paper label. Label states " ** Pretzels The Huckleberry People 1021 Waverly Street Missoula, MT. NET WT. ** oz ** INGREDIENTS: WHITE CHOCOLATE, ** OIL, AND PRETZELS. Flavors include: a) Wild Huckleberry, net wt 6.9 oz pkg. Recall # F-459-2; b) Red Raspberry, net wt. 6.9 oz. pkg. Recall # F-460-2; c) Cranberry, net wt. 7.9 oz. pkg. Recall # F-461-2; d) Wild Blueberry, net wt. 6.9 oz. pkg. Recall # F-462-2. CODE Individual consumer packages are not coded. RECALLING FIRM/MANUFACTURER Montana Huckleberry Treasures, dba The Huckleberry People, Missoula, MT, by letters on January 25, 2002. State initiated recall is complete. REASON The products listed white chocolate and pretzels as ingredients without listing their sub-ingredients. The white chocolate contained nonfat milk powder and the pretzels contained soft red wheat flour. VOLUME OF PRODUCT IN COMMERCE a) 2117 pkgs; b) 338 pkgs; c) 148 pkgs; d) 60 pkgs. DISTRIBUTION Nationwide. _______________________ PRODUCT Golden, Glorious & Pure Local Raw Ozark Honey Butter packaged in 2-oz., 6-oz. and 12-oz. glass jars with a sticker on the lid indicating the flavor. a) Blueberry Nut, Recall # F-463-2; b) Maple Nut, Recall # F-464-2; c) Pecan, Recall # F-465-2. CODE Uncoded. RECALLING FIRM/MANUFACTURER Golden, Glorious & Pure Honey Heaven, Springfield, MO, by press release on February 12, 2002 and by telephone and mail beginning on February 13, 2002. FDA initiated recall is complete. REASON Undeclared pecans. VOLUME OF PRODUCT IN COMMERCE 25/2-oz; 36/6-oz; & 15/12-oz. DISTRIBUTION MO.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Golden, Glorious & Pure Local Raw Ozark Clover Honey identified with a sticker on the lid indicating the flavor. The products are all whipped honey and are packed in 2-oz, 6-oz, or 12-oz. glass jars. The Peach flavor also comes in an unwhipped form for pouring into tea and is packed in 2-oz, 6-oz, or 12-oz. plastic bear squeeze bottles. a) Peach, Recall # F-466-2; b) Apricot, Recall # F-467-2; c) Blackberry, Recall # F-468-2. CODE Uncoded. RECALLING FIRM/MANUFACTURER Golden, Glorious & Pure Honey Heaven, Springfield, MO, by press release on February 12, 2002 and by telephone and mail beginning on February 13, 2002. FDA initiated recall is complete. REASON Undeclared FD&C Yellow #5 and #6. VOLUME OF PRODUCT IN COMMERCE Unable to determine. DISTRIBUTION MO.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT Golden, Glorious & Pure Local Raw Ozark Clover Honey identified with a sticker on the lid indicating the flavor. The products are all whipped honey and are packed in 2-oz, 6-oz, or 12-oz. glass jars. a) F-469-2 Walnut, Recall # F-469-2; b) F-470-2 Maple Pecan Honey Syrup, Recall # F-470-2. CODE Uncoded. RECALLING FIRM/MANUFACTURER Golden, Glorious & Pure Honey Heaven, Springfield, MO, by press release on 2/12/02 and by telephone and mail beginning on February 13, 2002. REASON Undeclared nuts, which may be obvious to consumers. VOLUME OF PRODUCT IN COMMERCE a) 14/2-oz; 10/6-oz; and 6/12-oz; b) 14/2-oz; 14/6-oz; and 3/12-oz. DISTRIBUTION MO.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Doxorubicin Hydrochloride Injection, USP, 50mg/25mL (2mg/mL), 25mL Single Dose Vial, Rx only. Recall # D-281-2. CODE Lot T049 Exp. 9/2002. RECALLING FIRM/MANUFACTURER Gensia Sicor Pharmaceuticals, Inc., Irvine, CA, by letter on May 17, 2002. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 20,520 vials. DISTRIBUTION Nationwide. _______________________ PRODUCT Combivent Inhalation Aerosol (ipratropium bromide 18 mcg and albuterol sulfate 103 mcg) 14.7g canister, 200 metered actuations, Rx only. Recall # D-283-2. CODE Lot Numbers: 165090A, Exp. Date May-03 165092A, Exp. Date May-03. RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by FED EX on May 21, 2002. Firm initiated recall is ongoing. REASON Defective container; inhaler may not fire properly and patients will not receive their full dose of medication. VOLUME OF PRODUCT IN COMMERCE 192,089 units total. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Gyne-Lotrimin Vaginal Antifungal Cream 3-Day Combination Pack (clotrimazole) 1%, vaginal inserts and 7 g (0.25 oz) tube, over-the- counter. Recall # D-282-2. CODE Tube Lot No. Combination Pack Lot No. Exp. Date 9KPE6 9CO513 09/30/2002 9KPE6 9CO514 09/30/2002 9KPE6 9CO512 09/30/2002 9KPE7 0CO501 09/30/2002 9KPE7 0CO502 09/30/2002 9KPE7 0CO500 09/30/2002 9KPE7 0CO503 09/30/2002 0KPE1 0CO504 01/30/2003 0KPE1 0CO505 01/30/2003 0KPE1 0CO506 01/30/2003 0KPE2 0CO507 04/30/2003 0KPE2 0CO508 04/30/2003 0KPE2 1CO500 04/30/2003 0KPE3 1CO501 08/30/2003 0KPE3 1CO503 08/30/2003 0KPE3 1CO505 08/30/2003 0KPE3 1CO504 08/30/2003 1KPE1 1CO506 01/30/2004. RECALLING FIRM/MANUFACTURER Recalling Firm: Schering-Plough HealthCare Products, Cleveland, TN, by letter on April 19, 2002. Manufacturer: Schering Laboratories, Kenilworth, NJ. Firm initiated recall is complete. REASON Degradation; specification failure (stability). VOLUME OF PRODUCT IN COMMERCE 494,880 packages. DISTRIBUTION Nationwide. _______________________ PRODUCT Rocaltrol (calcitriol) Oral Solution, 1 mcg/ml, 15 ml bottles, Rx only. Recall # D-284-2. CODE Lot Number: U0005 exp. 2/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Laboratories Nutley, NJ, by letters on April 19, 2002. Manufacturer: Hoffmann La Roche, Nutley, NJ. Firm initiated recall is ongoing. REASON Subpotent; active ingredient calcitriol (18 month stability). VOLUME OF PRODUCT IN COMMERCE 5,692 bottles. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1038-2. CODE Units 12FG83592, 12FR73622. RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC, by letter dated November 30, 2001. Firm initiated recall is ongoing. 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 NC. _______________________ PRODUCT Source Plasma, Recall # B-1093-2. CODE Units 58991008, 57110813, 57108582. RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services, L.P., North Brunswick, NJ, by fax dated July 19, 2001. Manufacturer: Biolife Plasma Services, L.P., Louisville, KY. Firm initiated recall is complete. REASON Blood products, collected from a donor who tested positive for syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1094-2. CODE Unit 29941704, 28489504. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ, by fax dated July 13, 2001. Manufacturer: Sera-Tec Biologicals Limited Partnership, Toledo, OH. Firm initiated recall is complete. REASON Blood products, collected from a donor who tested positive for syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1095-2. CODE Unit 29944910. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals Limited Partnership, New Brunswick, NJ, by fax dated March 14, 2001. Manufacturer: Sera-Tec Biologicals Limited Partnership, Toledo, OH. Firm initiated recall is complete. REASON Source Plasma, with an elevated alanine aminotransferase (ALT), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1096-2; b) Recovered Plasma, Recall # B-1097-2. CODE a) and b) Unit 1849482. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter and fax dated February 28, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who had a tattoo applied within twelve months of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION KY and NJ. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-1298-2; b) Cryoprecipitate, Recall # B-1299-2. CODE a) and b) Unit H60999. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by telephone or fax on November 13, 2001 and by letter on November 29, 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 indeterminate for Hepatitis C, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL and NC. _______________________ PRODUCT Capture-P Ready Screen Kit (Platelet Antibody Detection System), Recall # B-1318-2. CODE Lot Number 06996; expiration date March 8, 2002. RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA, by letter dated January 31, 2002. Firm initiated recall complete. REASON Test kits were incorrectly packaged with Capture-P Ready Screen 1-test strips, instead of 6-test plates. VOLUME OF PRODUCT IN COMMERCE 61 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Platelets, Pheresis, Recall # B-1329-2. CODE Unit 7400918. RECALLING FIRM/MANUFACTURER Manatee Community Blood Centers, Inc., Bradenton, FL, by telephone and fax on June 21, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who had the oral typhoid immunization, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1330-2. CODE Units 21381-8437, 21381-9338, 21381-9340, 21382-0020, 21382-0034, 21382- 0243, 21382-0549, 21382-0752 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 2, 2001. Manufacturer: United Blood Services, Fargo, ND. Firm initiated recall is complete. REASON Red Blood Cells, with incomplete compatibility testing performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION ND. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1332-2; b) Recovered Plasma, Recall # B-1333-2. CODE a) and b)Unit number 3799828. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on October 1, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION FL and NJ. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1334-2. CODE Unit number 01LZ23852 RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by telephone on August 14, 2001 and by letter dated August 17, 2001. Manufacturer: American Red Cross Blood Services, New York-Penn Region, Buffalo, NY. 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 OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT Source Plasma, Recall # B-1335-2. CODE Unit numbers 306U9118AB, 306U9138AB, 306U9157AB, 306U9178AB, 306U9178AB, 306U9204AB, 306U9237AB, 306U9254AB, 306U9283AB, 306U9401AB, 306U9415AB, 306U9751AB, 306U9764AB, 306U9797AB, 306U9810AB, 303FR731AB, 306U9651AB, 306U9659AB, 306U9669AB, 306U9676AB, 306U9684AB, 306U9695AB, 306U9716AB, 306U9740AB, 306U9871AB, 306U9885AB, 306U9902AB, and 306U9910AB. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Lincoln, NE, by fax on March 27, 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 risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 27 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT Capture-P? Solid Phase Test System, Recall # B-1339-2. CODE Lot number 10098. RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA, by telephone on or about March 4, 2002. Firm initiated recall is complete. REASON Test for antibodies to platelets were distributed with a component that expired prior to the labeled expiration date of the kit. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION Nationwide and Europe. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-1345-2; b) Fresh Frozen Plasma, Recall # B-1346-2; c) Red Blood Cells, for Manufacturing Use Only, Recall # B-1347-2; d) Recovered Plasma, Recall # B-1348-2. CODE a) and b) Unit 0680866; c) and d) Unit 0733361. RECALLING FIRM/MANUFACTURER Memorial Blood Center, Minneapolis, MN, by letter dated July 13, 2000. 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 MN, MI and PA. _______________________ PRODUCT a) Platelet, Pheresis, Leukoreduced, Recall # B-1349-2. b) Platelet, Pheresis, Leukoreduced Irradiated, Recall #B-1350-2; c) Red Blood Cells, Recall # B-1351-2; d) Platelets, Recall # B-1352-2; e) Fresh Frozen Plasma, Recall # B-1353-2 CODE a) Units 32KP20191(Split), 32KP20106(Split), 32KP19540; b) Unit 32KP19540; c); d) and e) Unit 32KC15534. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by letter dated July 16, 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 indeterminate for Hepatitis C, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION IL, WI and OH. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1355-2; b) Platelets, Leukocytes Reduced, Recall # B-1356-2. CODE a) and b)Unit number 17KN79755. RECALLING FIRM/MANUFACTURER The American National Red Cross, North Central Region, St. Paul, MN, by letter on March 30, 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 MN. _______________________ PRODUCT Red Blood Cells, Recall # B-1357-2. CODE Unit number G82310. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by letter dated October 5, 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 FL. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1358-2. CODE Unit number K16225. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by telephone on May 28, 2000. Firm initiated recall is complete REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1359-2. CODE Unit number 1829221. RECALLING FIRM/MANUFACTURER Siouxland Community Blood Bank, Sioux City, IA, by telephone August 24, 2001. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1360-2. CODE Unit number 4092505. RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH, by letter dated March 27, 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 OH. _______________________ PRODUCT Red Blood Cells, Recall # B-1361-2. CODE Unit number 1110704. RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH, by letters dated February 19 and March 21, 2002 and by telephone on April 5, 2002. Firm initiated recall is ongoing. 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 OH. _______________________ PRODUCT Red Blood Cells, Recall # B-1362-2. CODE Unit number 0667778. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center,Cincinnati, OH, by letter on February 8, 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 1 unit. DISTRIBUTION KY. _______________________ PRODUCT Red Blood Cells, Recall # B-1363-2. CODE Unit number 0667882. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated February 8, 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 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1364-2. CODE Unit numbers 16GV00070 and 16KC17218. RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Ohio Region, Columbus, OH, by letter on April 12, 2002. 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 OH. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B1365-2. CODE Unit.number 32GP13860. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Badger-Hawkeye Region, Madison, WI, by telephone on or about November 9, 2000. Manufacturer: The American National Red Cross, Green Bay, WI. Firm initiated recall is complete. REASON Blood product, corresponding to a unit of Platelets that was possibly contaminated with Clostridium sp. bacteria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1366-2. CODE Unit number 17KW30862. RECALLING FIRM/MANUFACTURER The American National Red Cross, North Central Region, St. Paul, MN, by telephone on February 19, 2001 and by fax on March 5, 2001. Firm initiated recall is complete. REASON Blood products, corresponding to a unit of Platelets that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MN and NY. _______________________ PRODUCT Red Blood Cells, Recall # B-1370-2. CODE Unit number 1776051. RECALLING FIRM/MANUFACTURER Siouxland Community Blood Bank, Sioux City, IA, by letter dated June 15, 2000. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to medication with the drug Proscar, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION SD. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1371-2; b) Cryoprecipitated AHF, Recall # B-1372-2; c) Plasma, Recall # B-1373-2. CODE a); b) and c) Unit number 32KE15914. RECALLING FIRM/MANUFACTURER The American National Red Cross, Badger-Hawkeye Region, Madison, WI, by telephone on April 21, 2000 and by letter on April 26, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the application of a tattoo, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL and WI. _______________________ PRODUCT Source Plasma, Recall # B-1374-2. CODE Unit numbers 33-3LM111, 33-3KJ644, 33-3KJ693, 33-3KJ835, 33-3KJ901, 33-3KK021, 33-3KK120, 33-3KK181, 33-3KK317, 33-3KK378, 33-3KK591, and 33-3KK668. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by letter on April 6, 1998. Manufacturer: Aventis Bio-Services, Inc., West Allis, WI. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 12 units. DISTRIBUTION Germany and France. _______________________ PRODUCT Source Plasma, Recall # B-1375-2. CODE Unit numbers 6R4734, 6R4789, 6R4944, 6R5014, 6R5215, 6R5304, 6R5378, and 6R5446. RECALLING FIRM/MANUFACTURER Recalling Firm: Centeon Bio-Services, Inc., Knoxville, TN, by letter on May 13, 1999. Manufacturer: Aventis Bio-Services, Inc. (formerly Centeon Bio-Services, Inc.), Minneapolis, MN. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1376-2. CODE Unit numbers 8W8065, 8W8131, 8W8274, 8W8353, and 8W8525. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by letter on July 7, 2000. Manufacturer: Aventis Bio-Services, Inc., Minneapolis, MN. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1377-2. CODE Unit number 46724106. RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS, by fax on June 28, 2001. Firm initiated recall is complete. REASON Blood product, that was not properly quarantined after the donor disclosed previous incarceration, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1378-2. CODE Unit number 21744068. RECALLING FIRM/MANUFACTURER Recalling Firm: Interstate Blood Bank, Inc., Memphis, TN, by letter on December 16, 1999. Manufacturer: Interstate Blood Bank, Inc., of Wisconsin, Milwaukee, WI. Firm initiated recall is complete. REASON Blood product, that was not properly quarantined after the donor disclosed previous incarceration, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1379-2. CODE Unit numbers 09293403, 08386618, 07837548, 07832291, 06949112, 0650222172, 0650222136, 0650222069, and 0650222011. RECALLING FIRM/MANUFACTURER Recalling Firm: Nabi, Boca Raton, FL, by fax on December 16, 1998. Manufacturer: ZLB Bioplasma, Inc. (formerly Nabi), Racine, WI. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to previous incarceration, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Platelet, Pheresis, Recall # B-1300-2. CODE Unit 22KG42465, 22KG42467. RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on January 3, 2001 and by letter dated January 11, 2001. Firm initiated recall is complete. REASON Blood products, labeled with extended expiration dates, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1336-2; b) Platelets Pheresis, Recall # B-1337-2; c) Platelets Pheresis, Leukocytes Reduced, Recall # B-1338-2. CODE a) Unit number 15 009-2350 (distributed as 2 split units); b) Unit numbers 15006-0519, 15006-8357, 15379-1924, 15380-9311, and 15006-0408; c) Unit numbers 15012-6382, 15386-3886, 15386-8101, 15386-8251, 15386-8561, 15387-1182, 15387-1726, 15387-1859, 15387-4449, and 15387-9358. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated July 5, 2001. Firm initiated recall complete. REASON Blood products, collected from an ineligible donor due to a history of Idiopathic Thrombocytopenic Purpura (ITP), were distributed. VOLUME OF PRODUCT IN COMMERCE 17 units. DISTRIBUTION TX. _______________________ PRODUCT Indicator Red Cells, Recall # B-1340-2. CODE Lot numbers 08006, 08007, and 08046, used in the following test kits: Capture-P? Test System, lot number 08038; Capture-P? Ready-Screen? Test System, lot numbers 08040 and 08041; Modified Capture-P? Test System, lot number 08039; Capture-CMV? Test System, lot numbers 08042, 08043, and 08043A; and Capture-S? Test System, lot numbers 08044, 08045, and 08045A. RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA, by letter dated February 14, 2002. Firm initiated recall is complete. REASON Test kits were distributed with indicator cells that may experience a loss of potency. VOLUME OF PRODUCT IN COMMERCE 3 lots. DISTRIBUTION Europe. _______________________ PRODUCT Capture-R? Ready-Screen? Test System, Recall # B-1341-2. CODE Lot numbers 37034 and 37035. RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA, by letter dated October 10, 2000. Firm initiated recall is complete. REASON Test kits were distributed that exhibited an increase in false positive tests. VOLUME OF PRODUCT IN COMMERCE 2 lots. DISTRIBUTION Nationwide, Europe, Canada and Australia. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1342-2; b) Platelets, Recall # B-1343-2; c) Recovered Plasma, Recall # B-1344-2; CODE a); b) and c) Unit number G70777. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by letter dated April 6, 2002. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to a history of surgery in the previous 6 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IA, MO and Switzerland. _______________________ PRODUCT Recovered Plasma, Recall # B-1367-2. CODE Unit number 17KW30862. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, North Central Region, St. Paul, MN, by telephone on February 19, 2001 and by fax on March 5, 2001. Manufacturer: The American Red Cross, St. Paul, MN. Firm initiated recall is complete. REASON Blood product, corresponding to a unit of Platelets that was possibly contaminated with Clostridium sp. bacteria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Washed, Recall # B-1368-2. CODE Unit numbers 24212-7084 and 24212-7096. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 3, 2001. Manufacturer: Blood Systems, Inc., Rapid City, SD. Firm initiated recall is complete. REASON Blood products that were out of controlled storage for more than 30 minutes were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION SD. _______________________ PRODUCT Source Plasma, Recall # B-1369-2. CODE Unit numbers 00LWID6857, 00LWID7203, 00LWID7848, 00LWID8397, 00LWID8903, 00LWIE0334, 00LWIE0584, 00LWIE1456, 00LWIE1925, 00LWIE2585, 00LWIE3071, 00LWIE3709, and 0LWIE4186 . RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by fax on November 28, 2000. Manufacturer: Community Bio-Resources, Inc., Onalaska, WI. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to a history of a human tissue transplant, were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units. DISTRIBUTION Austria. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall # B-1380-2. CODE Units 40FP12757, 40FP127562 (Split unit), 40P82325 (Split unit), 40P82328. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by telephone on June 4, 2001. Manufacturer: American Red Cross Blood Services, Heart of America Region, Peoria, IL. Firm initiated recall is complete. REASON Blood products, which were stored at unacceptable temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION IL.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________ PRODUCT LTV Series Ventilators. Models: a) LTV 1000 (cat. no. 10130), Recall # Z-1047-2; b) Model LTV 950 (cat. no. 10950), Recall # Z-1048-2; c) Model LTV 900 (cat. no. 10638), Recall # Z-1049-2; d) Model LTV 800 (cat. no. 11800), Recall # Z-1050-2. CODE Forthcoming. RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc., Colton, CA, by letter on March 12, 2002. FDA initiated recall is ongoing. REASON Shorts to inoperative condition. VOLUME OF PRODUCT IN COMMERCE 1,890 finished devices and 82 turbine assemblies. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT Ti Cann Troch Fixation Nail. Trochanteric Fixation Nail. Recall # Z-1056-2/Z-1066-2. CODE Part number 456.318S, lot numbers 4333900 exp. 11/10, 4333901 exp. 12/10, and 4340289 exp. 12/10. Part number 456.322S, lot numbers 4333904 exp. 11/10, 4340293 exp. 12/10, 4340295 exp. 12/10. Part number 456.325S, lot number 4320398 exp. 12/10. Part number 456.328S, lot number 4320395 exp. 12/10. Part number 456.414S, lot number 4349527 exp. 12/10. Part number 456.416S, lot numbers 4333921 exp. 11/10, 4333922 exp. 11/10, 4340324 exp. 12/10, and 4348124 exp. 12/10. Part number 456.418S, lot number 4340328 exp. 12/10. Part number 456.421S, lot number 4340334 exp. 12/10. Part number 456.422S, lot number 4333929 exp. 11/10. Part number 456.425S, lot number 4346091 exp. 12/10. Part number 456.511S, lot number 4348136 exp. 12/10. Part number 456.322S, lot number 4333903 exp. 12/10. RECALLING FIRM/MANUFACTURER Recalling Firm: Synthes (USA), Paoli, PA, by letters on January 21, 2002. Manufacturer: Synthes (USA), Monument, CO. Firm initiated recall is ongoing. REASON Hole not properly centered. VOLUME OF PRODUCT IN COMMERCE 71 units. DISTRIBUTION Nationwide and Switzerland. _______________________ PRODUCT Hill-Rom brand Horizon P100705 monitor slide. Recall # Z-1067-2. CODE All units built prior to May 2001. RECALLING FIRM/MANUFACTURER Hill-Rom Co. Inc., Batesville, IN, by letter beginning on April 30, 2002. Firm initiated recall is ongoing. REASON Monitor may fall. VOLUME OF PRODUCT IN COMMERCE 381 units. DISTRIBUTION Nationwide and Egypt. _______________________ PRODUCT a) Ballard Express Pre-Assembled Biliary Stent Systems. Recall # Z-1068-2; b) Ballard Standard Biliary Stent Sets with and without guide wire. Recall # Z-1069-2; c) Ballard Holland Biliary Stent Sets with and without guide wire. Recall # Z-1070-2; d) Ballard Pancreatic Stent Sets with and without guide wire. Recall # Z-1071-2; All sets are packaged in sterile 1-each package. CODE a) Catalog Number: 63000 Lot numbers: 101296, 120483, 122702, 125804, 126787, 128723, 129804, 132833, 142812, 151458, 156020, 91425, 91426, 91427 Catalog Number: 63001 Lot Numbers: 101297, 102446, 103780, 107268, 110876,117880 1125805, 128187, 128724, 130780, 133712, 137831, 139088, 156997, 160503, 165093. Catalog Number: 63002 Lot Number: 101298, 102454, 103781, 109316, 116585, 120484, 121332, 122703, 127468, 128725, 128993, 137023, 139993, 144126, 146988, 148556, 150150, 152326, 157776, 165094, 99726. Catalog Number: 63003 Lot Number: 101299, 102455, 107269, 119047, 120485, 121333, 122704, 126788, 128726, 129805, 131552, 135976, 144190, 158318. Catalog Number: 63004 Lot Number: 101300, 120486, 121334, 125554, 125806, 128727, 128994, 132045, 135977. Catalog Number: 63005 Lot Number: 101301, 1119749, 120487, 121335, 125555, 125807, 128188, 128728, 130781, 133713, 134524, 135394, 140688, 142813, 144128, 144191, 165095. Catalog Number: 63006 Lot Number: 101302, 125556, 128729, 128995, 129806, 132834, 135395, 135979, 139089, 142814, 143480, 148557. Catalog Number: 63007 Lot Number: 101303, 125557, 139995, 142107, 143481, 144129, 146989, 149414, 150151, 151459, 152327, 156022. Catalog Number: 63008 Lot Number: 101304, 125559, 132504, 135396, 135980, 138023, 140689, 142815, 144192, 153100, 156999, 158320, 160505, 165096. Catalog Number: 63009 Lot Number: 121336, 125560, 128189, 132505, 135981, 139090, 141320. Catalog Number: 63130 Lot Number: 137415, 139095, 141325, 145264. Catalog Number: 63131 Lot Number: 137416, 140000, 144743, 145265, 146110. Catalog Number: 63132 Lot Number: 137417, 144744, 144972. Catalog Number: 63133 Lot Number: 137418, 145267, 147015. Catalog Number: 63134 Lot Number: 137419 b) Catalog Number: 63040 Lot Number: 101161, 125561, 138028. Catalog Number: 63041 Lot Number: 101162, 125562, 146095. Catalog Number: 63042 Lot Number: 101163, 125563. Catalog Number: 63043 Lot Number: 101164, 125564. Catalog Number: 63044 Lot Number: 101165, 125565, 150153. Catalog Number: 63045 Lot Number: 101166 Catalog Number: 63046 Lot Number: 101167, 125567. Catalog Number: 63047 Lot Number: 101168, 125568, 140691, 143483, 154735, 157309, 160462, 160506. Catalog Number: 63048 Lot Number: 101169, 119753, 125569, 128720, 129813, 132837, 135397, 135982, 138029, 139091. Catalog Number: 63049 Lot Number: 101170, 125570, 130782, 133714, 135398, 135983. Catalog Number: 63050 Lot Number: 102456, 125571. Catalog Number: 63051 Lot Number: 125572. Catalog Number: 63052 Lot Number: 125573, 130783, 133715. Catalog Number: 63053 Lot Number: 125574, 128722. Catalog Number: 63054 Lot Number: 125575. Catalog Number: 63055 Lot Number: 125576. Catalog Number: 63056 Lot Number: 101183, 109317, 127855, 128767,129814, 138030. Catalog Number: 63057 Lot Number: 125577. Catalog Number: 63058 Lot Number: 125578. Catalog Number: 63061 Lot Number: 112612, 125581. Catalog Number: 63062 Lot Number: 101187, 125582, 142426. Catalog Number: 63063 Lot Number: 101188, 125583, 141321. Catalog Number: 63084 Lot Number: 101206, 125590. Catalog Number: 63085 Lot Number: 102495, 125591. Catalog Number: 63086 Lot Number: 101207, 125592. Catalog Number: 63087 Lot Number: 101208, 125593. Catalog Number: 63088 Lot Number: 125594. Catalog Number: 63089 Lot Number: 101210, 125595, 128762, 130784, 133717. Catalog Number: 63090 Lot Number: 103784, 125596, 131553, 134526, 135474, 137832, 138025, 144130, 145262, 149422. Catalog Number: 63091 Lot Number: 101211, 125597, 131554, 131690, 134527, 137833, 138026, 139996, 143489, 146102, 147000, 150157. Catalog Number: 63092 Lot Number: 101212, 125598, 128763, 132838, 135984, 138027, 142110. Catalog 63093 Lot Number: 101213, 125599. Catalog Number: 63094 Lot Number: 101214, 125600. Catalog Number: 63095 Lot Number: 102498, 125601. Catalog Number: 63096 Lot Number: 125602 Catalog Number: 63097 Lot Number: 125603 Catalog Number: 63150 LotNumber: 103791 Catalog Number: 63165 Lot Number: 103792, 105512. Catalog Number: 63166 Lot Number: 101049, 103893, 108831, 144139. Catalog Number: 63167 Lot Number: 103794, 112611. Catalog Number: 63168 Lot Number: 101050. Catalog Number: 63169 Lot Number: 122712, 130786. Catalog Number: 63171 Lot Number: 101053. Catalog Number: 63172 Lot Number: 101054, 128766. Catalog Number: 63173 Lot Number: 101055 Catalog Number: 63174 Lot Number: 101056. c) Catalog Number: 63010 Lot Number: 91422, 91424. Catalog Number: 63012 Lot Number: 101147, 119750. Catalog Number: 63013 Lot Number: 105952, 120489. Catalog Number: 63015 Lot Number: 119751. Catalog Number: 63016 Lot Number: 101151, 128773, 132835. Catalog Number: 63017 Lot Number: 101152, 128774, 132836, 155223, 156555. Catalog Number: 63018 Lot Number: 101153, 129811, 146991, 157308. Catalog Number: 63020 Lot Number: 105953, 120492. Catalog Number: 63023 Lot Number: 101159 Catalog Number: 63070 Lot Number: 101193, 118685, 137027. Catalog Number: 63071 Lot Number: 101194, 128770. Catalog Number: 63072 Lot Number: 101195, 127469. Catalog Number: 63073 Lot Number: 101196, 118686, 148560. Catralog Number: 63074 Lot Number: 101197, 121305, 127470, 143485. Catalog Number: 63075 Lot Number: 101198, 128772, 161901. Catalog Number: 63076 Lot Number: 101199, 118687, 138024, 143486, 148957. Catalog Number: 63077 Lot Number: 101200, 122706, 143487, 144871. Catalog Number: 63078 Lot Number: 101201, 119754. Catalog Number: 63079 Lot Number: 101202, 120496, 137028. Catalog Number: 63080 Lot Number: 101203, 118688, 146101. Catalog Number: 63081 Lot Number: 101204, 103782, 107270, 119755, 120497, 121306, 137029, 141322, 143488, 145261, 148561. Catalog Number: 63082 Lot Number: 103783, 112062, 127856, 137030, 150939. Catalog Number: 63083 Lot Number: 101205, 119756. d) Catalog Number: 63175 Lot Number: 146116, 155441, 91410. Catalog Number: 63176 Lot Number: 101057, 119763, 125618, 128918, 134531, 158321. Catalog: 63177 Lot Number: 101058, 119764, 125619, 128194. Catalog Number: 63178 Lot Number: 101059, 119765, 125620. Catalog Number: 63179 Lot Number: 101060. Catalog Number: 63181 Lot Number: 125623, 126790, 128783, 129821, 132056. Catalog Number: 63182 Lot Number: 101063, 125624, 128195. Catalog Number: 63183 Lot Number: 125625 Catalog Number: 63184 Lot Number: 101065, 125626. Catalog Number: 63185 Lot Number: 101066, 91416, 91417, 91418. Catalog Number: 63186 Lot Number: 101067, 105513, 126791, 128735, 132843. Catalog Number: 63187 Lot Number: 101068, 107272, 125627, 132844. Catalog Number: 63188 Lot Number: 101069, 125628, 132845. Catalog Number: 63189 Lot Number: 101070, 125629, 128196, 132846. Catalog Number: 63190 Lot Number: 101071, 125630, 127859, 130789, 132847. Catalog Number: 63191 Lot Number: 101072, 105514, 126793, 130790, 132848. Catalog Number: 63192 Lot Number: 101073, 109325, 111068, 132058. Catalog Number: 63193 Lot Number: 101074, 119766, 125631, 132849, 135994, 140003. Catalog Number: 63194 Lot Number: 101075, 125632, 130791, 132850. RECALLING FIRM/MANUFACTURER Recalling Firm: Ballard Medical Products Draper, UT, by letter on April 8, 2002. Manufacturer: Ballard Medical Products, Pocatello, ID. Firm initiated recall is ongoing. REASON Stent anchor wings may not project, thereby failing to anchor stent. VOLUME OF PRODUCT IN COMMERCE 6,312 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Portex Tracheostomy Tube, Laryngectomy tube, and Nasopharyngeal Airway products as follows: Flex D.I.C.(TM) Trach Tubes, Product Number 504070 504080 504090 505070 505080 505090 505100. Recall # Z-1072-2; D.I.C.(TM) Trach Tubes Product Number 502060 502080 502090 503060 503070 503080 503090 503100 512060 512080 512090 513070 513080. Recall # Z-1073-2; Laryngectomy Tube Product Number 562090. Recall # Z-1074-2; Nasopharyngeal Airway Product Number 340060 340070 340080 340090. Recall # Z-1075-2; Pediatric Trach Tubes Product Number 555030 555035 555040 555050 555055. Recall # Z-1076-2; Per Fit (R) Percutaneous Trach Tubes Product Number 522070 522080 522090. Recall # Z-1077-2; Lo Profile Trach Tube Product Number 592070. Recall # Z-1078-2; Blue Line(R) Trach Tubes Product Number 508070 518070 518090 521070 521080 521090 530060 530070 530080 530090 531080 531100 550060 550070 550080 550090.Recall # Z-1079-2. CODE Portex Tracheostomy Tube, Laryngectomy Tube, and Nasopharyngeal Airway Products with the Lot Numbers listed below: Flex D.I.C.(TM) Trach Tubes Product Number Lot Number 504070 K108407 504080 110562, K108408 504090 108359, K108409 505070 109606, 110184, 110625,K101267, K101268, K112021 505080 108657 505090 108679, 110219, K101160, K112025 505100 108728, K105823 D.I.C.(TM) Trach Tubes Product Number Lot Number 502060 109233 502080 K109382 502090 108614, K111020 503060 111010, 111072, K107619, K109385 503070 110075, 111482 503080 109057, 110632, 111069, 111070, K103444, K107019, K107021, K107620, K112685, K112686 503090 108356, 108466 503100 K112023 512060 K105824, K109398, K112345 512080 K107023 512090 108616 513060 K106753 513070 111484, 111485 513080 K102747, K112026 Laryngectomy Tube Product Number Lot Number 562090 108468 Nasopharyngeal Airway Product Number Lot Number 340060 111187 340070 111073, K100232, K108108 340080 111582 340090 111388, K109963 Pediatric Trach Tubes Product Number Lot Number 555030 K103059 555035 K107624 555040 111488, K102749 555050 K108417 555055 K106090 Per Fit (R) Percutaneous Trach Tubes Product Number Lot Number 522070 108683, 111337 522080 111096 522090 111097, 111120, 111577 Lo Profile Trach Tube Product Number Lot Number 592070 K101755 Blue Line(R) Trach Tubes Product Number Lot Number 508070 109132 518070 108127, 109134 518090 109135, K108443 521070 111006 521080 110626, K112122 521090 110633, K108444 530060 110628, K105829 530070 110113, 111270 530080 109511, K101751, K101752, K101753, K112125 530090 K108445 531080 K105831 531100 108681 550060 K103057 550070 K105832 550080 K103058 550090 K108415. RECALLING FIRM/MANUFACTURER Recalling Firm: Sims Portex, Inc., Keene, NH, by letter on May 3, 2002. Manufacturer: Portex, Inc., Keene, NH. Firm initiated recall is ongoing. REASON Product package may have defective seals and compromise sterility of device. VOLUME OF PRODUCT IN COMMERCE 22,794 units. DISTRIBUTION Nationwide and Bahamas, Canada, Puerto Rico, Mexico and the United Kingdom. _______________________ PRODUCT AXIS/IRIX Gamma Camera System. A Prism XPVT System, Tomography, Computed, Emission, 90KPS System. Recall # Z-1080-2. System Catalog # Gantry S/N affected AXIS 210714 094-193 AXIS 210880 101-291 AXIS 211037 181-613 AXIS 211039 140-613 IRIX 210857 096-177,435 IRIX 210881 102-167 IRIX 211038 190-613 IRIX 211040 096-613. CODE Serial Numbers: 094 through 613. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems, fka: Picker International, Inc., Highland Heights, OH, by letter on April 8, 2002. Firm initiated recall is ongoing. REASON If the patient table is lowered onto a nearby object, such as a gurney, it may cause it to tip over. VOLUME OF PRODUCT IN COMMERCE 500. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT INRAD brand Express core biopsy device, single use, disposable, sterile; 18 gauge x 15 cm. Catalog # 901518. Recall # Z-1081-2. CODE Lot 6020-1003, exp. 1/2005. RECALLING FIRM/MANUFACTURER Recalling Firm: INRAD, Inc., Kentwood, MI, by telephone on April 18, 2002. Manufacturer: Arlanda Medicinska Instrument Co. AB, Sollentuna, Firm initiated recall is complete. REASON Extended expiration date on outer carton. VOLUME OF PRODUCT IN COMMERCE 105. DISTRIBUTION CA, SC, PA, TN and WA.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT BioFlavor F2425, BioFlavor F21002 and BioFlavor C20058. The product, packaged in 50 lb. bags, is labeled in part, " *** PALATABILITY ENHANCER INTENDED FOR CAT FOOD USE AT LESS THAN 10% *** INGREDIENT LISTING: *** Beef Broth *** ". Recall # V-140-2 CODE Product Codes F2425 107B-RB-1 107B-RB-2 149C 201D 202C 205D 210A F21002 143B 143D 146D 144B 144D 139D 142D 150D 151D 152C 152D 201C 205C 206C 208A 211A C20058 143D 144C 146C 208B RECALLING FIRM/MANUFACTURER Recalling Firm: Bioproducts, Inc., Fairlawn, OH, by telephone and letter on April 5, 2002. Manufacturer: Bioproducts, Inc., Aurora, MO. Firm initiated recall is ongoing. REASON Animal feed product with beef protein does not contain required BSE statement on labels. VOLUME OF PRODUCT IN COMMERCE 354,150 lbs. DISTRIBUTION TX, KS, MO and MI. _______________________ PRODUCT Steamed Bonemeal in 50-lb. bags, product code C# 13581, packaged under two different labels: Premium Steamed Bonemeal Manufactured by Buchheit Premium Feeds, Perryville, MO, and Steamed Bonemeal Manufactured for Siemer's Enterprises Inc., Teutopolis, IL. Recall # V-141-2. CODE Not coded. RECALLING FIRM/MANUFACTURER Buchheit, Inc., Perryville, MO, by telephone on May 14, 2002. FDA initiated recall is ongoing. REASON Label lacks BSE warning statement. VOLUME OF PRODUCT IN COMMERCE Approx. 902/50-lb. bags. DISTRIBUTION MO and IL.END OF ENFORCEMENT REPORT FOR JUNE 5, 2002 ####
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2002-JUN-06