May 1, 2002 02-17
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT TOFT'S Moosetrack Ice Cream Cakes, in 3lb 4oz round or 5lb rectangular sheets, packaged in plastic dome containers. Recall # F-382-2. CODE The product is not coded. RECALLING FIRM/MANUFACTURER Toft's Ice Cream Parlor, Port Clinton, OH, by visit on November 26, 2001 and by press release on November 30, 2001. Firm initiated recall is complete. REASON The product contains undeclared peanut butter. VOLUME OF PRODUCT IN COMMERCE 12. DISTRIBUTION OH.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT a) Cinnamon-Vanilla Toffee Candy pieces. Recall # F-379-2; b) Vanilla Toffee Candy pieces. Recall # F-380-2. These toffee pieces are found in the following gift items: 1) Dardee Candies Brand Christmas Mug with candy, 1.8 oz, item #DC155 and #CP155, 36 containers per case - vanilla toffee; 2) Creative Candies Brand Ceramic Heart Dish with candy, 1.8 oz, item #CP346, 24 containers per case - cinnamon vanilla toffee; 3) Creative Candies Brand Square Heart Votive holder with candy, 2 oz, item #CP349, 36 containers per case - vanilla toffee; 4) Creative Candies Brand Ceramic Valentine gift bag with candy, 1.8 oz, item #CP350, 48 containers per case - cinnamon vanilla toffee; 5) Creative Candies Brand Ceramic Valentine Mug with candy, 1.8 oz, item #CP351, 48 containers per case - cinnamon vanilla toffee; 6) Creative Candies Brand Ceramic Planter with candy, 6 oz, item #CP377, 12 containers per case - vanilla toffee; 7) Creative Candies Brand Ceramic Rabbit Planter with candy, 3.4 oz, item #CP378, 12 containers per case - vanilla toffee; 8) Creative Candies Brand Ceramic Bag with candy, 2.7 oz, item #CP380, 48 containers per case - vanilla toffee; 9) Creative Candies Brand Ceramic Bag with candy, 2 oz, item #CP381, 60 containers per case - vanilla toffee; 10) Creative Candies Brand Ceramic Egg Bow Dish with candy, 2 oz, item #CP390, 48 containers per case - vanilla toffee; 11) Creative Candies Brand Ceramic Laying Bunny with candy, 2 oz, item #CP391, 36 containers per case - vanilla toffee; 12) Creative Candies Brand Cracked Glass Votive holder with candy, 5.4 oz, item #CP394, 48 containers per case - cinnamon vanilla toffee; 13) Creative Candies Brand 9 inch Cracked Glass Vase with candy, 8 oz, item #CP405, 36 containers per case - cinnamon vanilla toffee; 14) Creative Candies Brand Ceramic Picture Frame with candy, 4.7 oz, item #CP430, 24 containers per case - vanilla toffee; 15) Creative Candies Brand Ceramic Rabbit Centerpiece with candy, 6.7 oz, item #CP431, 12 containers per case - vanilla toffee; 16) Creative Candies Brand Ceramic Candle Burner with candy, 2 oz, item #CP452, 48 containers per case - vanilla toffee; 17) Creative Candies Brand Jade Angel Dish with candy, 1.8 oz, item #CP453, 48 containers per case - cinnamon vanilla toffee; 18) Creative Candies Brand Cracked Glass Votive Holder with candy, 4.7 oz, item #CP500, 48 containers per case - cinnamon vanilla toffee; 19) Creative Candies Brand Ceramic Easter Tumbler with candy, 1.3 oz, item #CP600, 72 containers per case - vanilla toffee. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Rod Loomis Sales, Transfer, PA, by letters on November 8, 2001. Manufacturer: Shantou Sunrise Foods Co., Shantou, China. FDA initiated recall is complete. REASON Products contained undeclared certifiable colors and non- permitted colors. VOLUME OF PRODUCT IN COMMERCE 2,991 cases. DISTRIBUTION Nationwide and the Dominican Republic and Canada.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT Albertsonís brand A+ Natural Spring Water in 1.5L bottles. Recall # F-381-2. CODE Expiration Date: 7-16-02 CMTR 6-25-01, 23:39 (this will be on the bottom of the bottle). RECALLING FIRM/MANUFACTURER Recalling Firm: Albertsonís, Inc., Meridian, ID, by e-mail on October 16, 2001. Firm initiated recall is complete. REASON The product contains mold. VOLUME OF PRODUCT IN COMMERCE 127 cases/12 bottles per case. DISTRIBUTION CA and NV.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
_______________________ PRODUCT PC SPES, Prostate Formula, Herbal Dietary Supplement, 60 capsules, 320 mg each, over-the-counter sales. Recall # D-198-2. Indicated for "prostate health" claim. An herbal dietary supplement containing Chinese herbs (Reishi, Baikal Skullcap, Rabdosia, Dyer's Woad, Mum, Saw Palmetto, San- Qi Ginseng, Licorice). CODE All lots and all codes. RECALLING FIRM/MANUFACTURER International Medical Research, dba Botanic Labs Inc., Brea, CA, by letter dated February 8, 2002. State initiated recall is ongoing. REASON The product contains the undeclared prescription drug; Warfarin VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Cromolyn Sodium Nasal Solution USP, Each spray delivers 5.2 mg cromolyn sodium,(40 mg/mL), 13 mL (100 sprays) and 26 mL (200 sprays) plastic spray pumps containers, Manufactured by Alpharma USPD under the following labels: Alpharma Cromolyn Sodium Nasal Solution USP Pfizer BenaMist Major Cromolyn Sodium Nasal Solution USP Perfect Choice Cromolyn Sodium Nasal Solution USP Kroger Cromolyn Sodium Nasal Solution USP Rite Aid Cromolyn Sodium Nasal Solution USP Walgreens Wal-Crom Longs Nasal Allergy Symptom Controller Eckerd Cromolyn Sodium Nasal Solution USP Equate Cromolyn Sodium Nasal Solution USP Good Neighbor Cromolyn Sodium Nasal Solution USP Leader Nasal Allergy Control Spray Savon/Osco Cromolyn Sodium Nasal Solution USP Valu-Rite Nasal Allergy Symptom Controller CVS Cromolyn Sodium Nasal Solution USP Family Pharmacy Nasal Allergy Symptom Controller Quality Choice Cromolyn Sodium Nasal Solution USP AAFES Nasal Allergy Symptom Controller Discount Drug Mart Cromolyn Sodium Nasal Solution USP Recall # D-239-2. CODE Lot Number Expiry Date RA1009 31-Jul-02 RA1010 31-Aug-03 RB1068 31-Jul-03 RB1069 31-Jul-03 RB1069 31-Aug-03 RC1136 30-Sep-03 RC1191 30-Sep-03 RC1192 30-Sep-03 RC1193 31-Oct-03 RC1194 31-Oct-03 RH1442 31-Oct-03 RH1444 31-Oct-03 RH1445 31-Oct-03 RH1447 30-Nov-03 RH1448 30-Nov-03 RH1449 30-Nov-03 RH1450 30-Nov-03 RH1451 30-Nov-03 RH1452 30-Nov-03 RH1453 31-Dec-03 RH1454 31-Dec-03 RH1455 31-Dec-03 RH1456 31-Dec-03 RH1457 31-Dec-03 RH1458 31-Dec-03 RH1459 31-Jan-04 RH1460 31-Jan-04 RH1461 31-Jan-04 RH1462 31-Jan-04 RH1463 31-Oct-03 RH1464 31-Oct-03 RH1465 31-Dec-03 RH1466 31-Oct-03 RH1467 31-Oct-03 RH1468 30-Nov-03 RH1469 31-Dec-03 RS0847 31-Jul-03. RECALLING FIRM/MANUFACTURER Alpharma USPD, Baltimore, MD, by letter on March 19, 2002. Firm initiated recall is ongoing. REASON Good Manufacturing Practice Deviations (CGMP): Product was manufactured under the same conditions that yielded contaminated (microbial) product. VOLUME OF PRODUCT IN COMMERCE 1,423,008 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Ranitidine Tablets, USP, 150 mg, Rx only, Unit-Dose Tablets. Recall # D-240-2. CODE Lot #4513-2002, Exp Date 7/31/02. RECALLING FIRM/MANUFACTURER NCS HealthCare of KY; d.b.a. Vangard Labs, Inc., Glasgow, KY, by letter, e-mail and fax on April 11, 2001. Firm initiated recall is ongoing. REASON Product name is mis-spelled on the outer carton label. VOLUME OF PRODUCT IN COMMERCE 1,056 cartons. DISTRIBUTION Nationwide. _______________________ PRODUCT Lovastatin Tablets, USP, 20mg, bottle of 60 tablets, NDC #0228-2634-06, Rx Only. Recall # D-243-2. CODE Lots 220F11, Exp. 6/03 221F11, Exp. 6/03. RECALLING FIRM/MANUFACTURER Purepac Pharmaceuticals, Elizabeth, NJ, by letters on February 25, 2002. Firm initiated recall is complete. REASON Product failed stability requirement for impurity level. VOLUME OF PRODUCT IN COMMERCE Lot 220F11 -- 826,080 tablets as 13,768/60 count bottles; Lot 221F11 -- 848,820 tablets as 14,147/60 count bottles . DISTRIBUTION Nationwide. _______________________ PRODUCT Urimax tablets in 100 count bottles and 2 tablet patient sample package, Rx, NDC 64731-860-01. Recall # D-244-2. Each tablet contains: Methenamine 81.60 mg Sodium Biphosphate 40.80 mg Phenyl salicylate 36.20 mg Methylene Blue 10.80 mg Hyoscyamine Sulfate 0.12 mg CODE Lots 01101, 10202, 10309, 10406, 10502, 108012, 109001 and 110083. RECALLING FIRM/MANUFACTURER Integrity Pharmaceutical Corp., Indianapolis, IN, by letter dated March 28, 2002. Firm initiated recall is ongoing. REASON Subpotent for one ingredient (hyoscyamine) at stabilty testing. VOLUME OF PRODUCT IN COMMERCE 55,800 bottles. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1061-2. CODE Unit 10710-8430. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 18, 2001. Manufacturing: United Blood Services, Scottsdale, AZ. Firm initiated recall is complete. REASON Blood product, which had a questionable weight, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells (Split unit), Recall # B-1101-2. CODE Unit 7475468. RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, by letter dated April 12, 2001. Firm initiated recall is complete. REASON Blood product, collected on equipment that had not been validated for use, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Recall # B-1102-2. CODE Unit 7569915. RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, by fax on April 2, 2001. Firm initiated recall is complete. REASON Blood product, collected on equipment that had not been validated for use, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1113-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1114-2; c) Platelets, Recall # B-1115-2. CODE a) Unit numbers 13GQ38081 and 13FM67664; b) Unit numbers 13FJ70697 and 13GQ49909; c) Unit numbers 13FJ70697, 13GQ49909, and 13FM67664. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region,Detroit, MI, by letter dated January 7, 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 7 units. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1116-2; b) Platelets, Recall # B-1117-2; c) Recovered Plasma, Recall # B-1118-2. CODE a); b) and c) Unit number 13FF26684. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated February 21, 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 3 units. DISTRIBUTION MI and Switzerland. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1119-2. CODE Unit number GS12348. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letter on December 12, 2001. Firm initiated recall is complete. REASON Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1120-2. CODE Unit number 13FR21364. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated December 11, 2001. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Source Plasma, Recall # B-1121-2. CODE Unit numbers TO359049, TO359002, TO358943, TO358916, TO358858, TO358824, TO358766, TO358738, TO358674, TO358650, TO358586, TO358558, TO358418, TO358339, TO358306, TO358208, TO358165, TO358075, TO358036, TO357956, TO357920, TO357826, TO357798, TO357693, TO357649, TO357544, TO357503, TO357415, TO357378, TO357172, TO357125, TO357008, TO356965, TO356790, TO356725, TO356593, TO356545, TO356429, TO356364, TO356258, TO356208, TO356107, TO356054, TO355954, TO355903, TO355715, and TO355685. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals Limited Partnership, BioLife Plasma Services, L.P., North Brunswick, NJ, by letters on April 27, 2001. Manufacturer: Sera-Tec Biologicals Limited Partnership, Toledo, OH. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 47 units. DISTRIBUTION MA. _______________________ PRODUCT Source Plasma, Recall # B-1122-2. CODE Unit numbers 05008704, 05010097, 03932537, 03933886, 03936306, 03937860, 03940273, 05271764, 26815831, 26819372, 26921389, 26922638, 26924526, 26925806, 26927213, 26928425, 26930114, 24771405, 24772884, 24774475, 24776462, 24777841, 24779708, 24731201, 24733069, 24734301, 24735773, 24737012, 24739764, 24740364, 30133105, 30133693, 30135741, 30136373, SD690332, SD690349, SD690422, SD690434, SD690492, SD690524, SD690559, SD690590, SD690639, and SD690681. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals Limited Partnership, BioLife Plasma Services, L.P., North Brunswick, NJ, by letter on July 18, 2001. Manufacturer: Sera-Tec Biologicals Limited Partnership, BioLife Plasma Services, L.P., Dayton, OH. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 44 units. DISTRIBUTION CA and MA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1125-2. CODE Unit number FG47702. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center,Providence, RI, by letter on January 10, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1126-2 b) Platelets, Leukocytes Reduced, Recall # B-1127-2; c) Fresh Frozen Plasma, Recall # B-1128-2. CODE a); b) and c) Unit number FM47817. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on January 29, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on body piercing within the previous twelve months, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MA and RI. _______________________ PRODUCT a) Platelets, Leukocytes Reduced, Recall # B-1129-2. b) Fresh Frozen Plasma, Recall # B-1130-2. CODE a) and b) Unit number FK39798. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on January 22, 2002. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to use of the medication Coumadin at the time of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION RI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1131-2; b) Platelets, Recall # B-1132-2. CODE a) and b) Unit number 22LN86137. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letters dated June 1, 2000 and June 30, 2000. 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 PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1133-2; b) Platelets, Recall # B-1134-2; c) Fresh Frozen Plasma, Recall # B-1135-2. CODE a); b) and c) Unit number 22LQ87649. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on October 5, 2001 and by letter on October 12, 2001. Firm initiated recall is complete. REASON Blood products, that were not appropriately quarantined after the donor, subsequent to the donation of the recalled products, reported behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NJ and PA. _______________________ PRODUCT Source Plasma, Recall # B-1143-2. CODE Unit number 00CIAA4989. RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Cedar Rapids, IA, by fax on March 10, 2000. Firm on label: Community Bio-Resources, Inc., Grand Rapids, MI. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to recent application of a tattoo, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _______________________ PRODUCT Source Plasma, Recall # B-1144-2. CODE Unit numbers 00CIAC1994, 00CIAC1474, and 00CIAB5628. RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Cedar Rapids, IA, by fax on July 28, 2000. Firm on label: Community Bio-Resources, Inc., Grand Rapids, MI. Firm initiated recall is complete. REASON Blood products, collected from donors whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jacob disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION Austria. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1145-2. CODE Unit 50C13227. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone on May 17, 2001 and by letter dated June 4, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who had a history of drug use, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1146-2. CODE Unit 21KL40355. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services,Portland, OR, by letters dated October 23, 2001 and December 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 CA. _______________________ PRODUCT Platelets, Recall # B-1150-2. CODE Unit number 4103784. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on September 11, 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 1 unit. DISTRIBUTION TX and NJ. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1152-2; b) Platelets, Recall # B-1153-2. CODE a) Unit numbers 3982598 and 4068621; b) Unit number 4068621. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on August 29, 2001. Firm initiated recall is complete. REASON Blood products, 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 TX. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1154-2; b) Platelets, Recall # B-1155-2; CODE a) and b) Unit number 4048712. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on August 21, 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 TX and NJ. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1157-2; b) Platelets, Recall # B-1158-2. CODE a) and b) Unit number 4017059. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on July 9, 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 TX and NJ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1160-2; b) Platelets Irradiated, Recall # B-1161-2. CODE a) Unit numbers 3619763 and 3643393; b) Unit number 3619763. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on July 26, 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 TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1162-2 CODE Unit number 4125752. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on August 29, 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 TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1163-2. CODE Unit number 11330-2731. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX, by letter on February 13, 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 TX. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1164-2; b) Recovered Plasma, Recall # B-1165-2. CODE a) and b) Unit number 11329-1769. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX, by letter on August 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Methotrexate, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX and VA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1166-2; b) Platelets, Recall # B-1167-2; c) Recovered Plasma, Recall # B-1168-2. CODE a) and c) Unit numbers 4124849, 4025209, and 4006335; b) Unit number 4124849. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on July 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION TX and PA. _______________________ PRODUCT a) Platelets Pheresis, Leukocytes Reduced, Recall # B-1169-2; b) Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1170-2; c) Plasma, Recall # B-1171-2. CODE a) Unit numbers 4104172, 4083014, and 4082903; b) Unit number 4082903; c) Unit number 4104130. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on July 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION TX.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Source Plasma, Recall # B-1123-2 CODE Unit numbers TO361990, 57122083, 58843956, 59159810, 59155492, 59153320, 59098201, 59030706, 59092094, 59031321, 59160076, 59034964, 59040316, 59156444, 59034650, 59032465, 59159483, 59038511, 59036692, 59159360, 59156581, 59100430, 59037453, 59160410, 59039280, 59036739, 59097877, 59152880, 59153269, 59156987, 61142534, 61157996, 61263703, 61268210, 61265851, 61261778, 61159327, 61155411, 61262348, 61151383, 61153325, 61262904, 61260849, 61263017, 61144729, 61140639, 61261297, 61144439, 61149915, 61147454, 61144323, 61262249, 61149854, 61143807, 61267596, 61262812, 61157347, 61263291, 61157859, 61152809, 61153493, 61143524, 61267855, 61267848, 61151727, 61159747, 61267800, 61265943, 61262744, 61267886, 61264342, 61266858, 61159914, 61154827, 61151895, 61147249, 61154209, 61266773, 61158269, 61159815, and 61263666. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals Limited Partnership, BioLife Plasma Services, L.P., North Brunswick, NJ, by letters on October 22 and 23, 2001. Manufacturer: Sera-Tec Biologicals Limited Partnership, BioLife Plasma Services, L.P., Toledo, OH. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from donors whose medical history screening was inadequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 81 units. DISTRIBUTION CA and Germany. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1136-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1137-2; c) Red Blood Cells, Irradiated, Recall # B-1138-2; d) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1139-2. CODE a) Unit numbers 22LW49435, 22FK85781, 22KT24204, 22GE53036, 22GE53039, 22GE53040, 22GE53041, 22GE53061, 22LW49490, 22KW22284, 22LV67872, 22LV67866, 22FM95319, 22GK75839, 22GK75846, 22GW67635, 22GW67636, 22GY96255, 22KC20140, 22KC20142, 22KX32016, 22GK68981, 22GK68982, 22GY96254, 22KM50552, 22KZ34950, 22LN84521, 22LN84524, 22LN84530, 22GY96251, 22KC18530, 22KP41999, 22KZ34936, 22FM95323, 22GE53044, 22GK68983, 22KC18526, 22KC18528, 22KK33210, 22KK33211, 22KT24206, 22KZ34937, 22KZ34938, 22KZ34940, 22LQ77081, 22LV67867, 22LV67873, 22LV67874, 22FK85793, 22GY96262, 22GY96263, 22GT99139, 22KZ34922, 22FK85790, 22FM95322, 22GE53038, 22GK75841, 22GY96248, 22GY96256, 22GY96264, 22GY96265, 22KC18529, 22KX23999, 22KX32005, 22LN84522, 22LN84526, 22LN84528, 22LN84529, 22LV67871, 22LW49566, 22GY96258, 22GY96260, 22KK33208, 22KK33209, 22KZ34939, 22FK85734, 22LQ77061, 22FM95321, 22KM50555, 22FK85797, 22KX32006, 22KZ34945, 22LQ77053, 22GK68976, 22KN16964, 22KX32001, 22KX32002, 22LV67858, 22FK85736, 22LQ77000, 22FK85779, 22KJ51781, 22KM50542, 22KM50544, 22KM50546, 22GE53047, 22KZ34947, 22FM95320, 22KP52002, 22LV67870, 22GE53037, 22KJ51779, 22KZ34921, 22GK68973, 22GW67631, 22KC18527, 22KZ34941, 22KZ34944, 22GT99092, 22FK85757, 22FK85758, 22FW74414, 22FW74415, 22GE53060, 22GE53082, 22GK75840, 22GW67638, 22KK33213, 22KZ34943, 22LQ77050, 22LQ77067, 22GY96257, 22GY96259, 22GY96261, 22GY96266, 22KN16960, 22KN16961, 22KN16962, 22KT24205, and 22KX23998; b) Unit numbers 22GE53081, 22FW74407, 22GW67633, 22KK33214, 22LQ77082, 22KC18522, 22LN84525, 22FM95310, 22GY96202, 22GE53042, 22GE53046, 22KC18535, 22KN16963, 22LN84527, 22LW49491, and 22GK68980; c) Unit numbers 22FK85735, 22FK85773, 22KC18533, 22KM50554, 22KX24000, 22LV67869, 22GE53045, 22GW67637, 22KC18523, 22KM50553, 22GY96249, 22KJ51780, 22KJ51782, 22FW74410, 22GK68974, 22GK68979, 22GW67634, 22GY96246, 22GY96247, 22KM50556, 22KN19887, 22KZ34946, and 22LY72573; d) Unit numbers 22LQ77005, 22LV67859, 22KK33212, 22LV67861, 22KC18524, 22KC18534, 22KN16959, 22KZ34949, 22GE52979, 22GK68975, and 22LY72595. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on June 23, 2000 and letters dated July 6, 2000 and August 4, 2000. Firm initiated recall is complete. REASON Blood products, that may have been out of specification for red blood cell recovery, were distributed. VOLUME OF PRODUCT IN COMMERCE 180 units. DISTRIBUTION NJ and PA. _______________________ PRODUCT Source Plasma, Recall # B-1140-2. CODE Unit number 99CIAF1089. RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Cedar Rapids, IA, by facsimile on January 7, 2000. Firm on label: Community Bio-Resources, Inc., Grand Rapids, MI. Firm initiated recall is complete. REASON Blood product, that tested negative for viral markers, but was collected from a donor whose medical history screening was inadequately performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _______________________ PRODUCT Source Plasma, Recall # B-1141-2 CODE Unit number 99CIAC0832. RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Cedar Rapids, IA, by fax on December 9, 1999. Firm on label: Community Bio-Resources, Inc., Grand Rapids, MI. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to recent immunization with hepatitis B vaccine, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _______________________ PRODUCT Source Plasma, Recall # B-1142-2. CODE Unit number 99CIAF3129. RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Cedar Rapids, IA, by fax on January 10, 2000. Firm on label: Community Bio-Resources, Inc., Grand Rapids, MI. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to recent immunization with hepatitis B vaccine, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _______________________ PRODUCT a) Red Blood Cells, Recall #B-1147-2. b) Red Blood Cells, Leukoreduced, Recall # B-1148-2; c) Red Blood Cells, For Further Manufacturing Use Only, Recall # B-1149-2. CODE a) Units 21FM59725, 21GC85348, 21GC85353, 21GC85369, 21GV05804, 21KL21586, 21KL21591, 21KL21618, 21KM14182, 21KM14206, 21KR08135, 21KR08155, 21KR08307, 21KR08308, 21KR08310, 21KR08311, 21KR08317, 21KR08329; b) Units 21FL41218, 21FL41230, 21FM59572, 21FM59590, 21FM59593, 21FM59608, 21FQ10839, 21GY62093, 21KE08539, 21KE08543, 21KG32929, 21KJ35096, 21KJ35099, 21KK24167, 21KK24250, 21KL21512, 21KL21519; c) Units 21KL21516, 21KL21550. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by letters dated June 21 and July 31, 2001. Firm initiated recall is complete. REASON Blood products, which were stored at incorrect temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION CA and MI. _______________________ PRODUCT Source Leukocytes, Recall # B-1151-2. CODE Unit number 4103784. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on September 11, 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 1 unit. DISTRIBUTION TX and NJ. _______________________ PRODUCT Source Leukocytes, Recall # B-1156-2. CODE Unit numbers 3988510 and 4048712. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on August 21, 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 TX and NJ. _______________________ PRODUCT Source Leukocytes, Recall # B-1159-2. CODE Unit number 4017059. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on July 9, 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 1 unit. DISTRIBUTION TX and NJ. _______________________ PRODUCT Antihemophilic Factor (recombinant), Kogenate, Recall # B-1172- 2. CODE Lot number 670J039. RECALLING FIRM/MANUFACTURER Bayer Corporation, Berkeley, CA, by electronic mail and letter on March 28, 2002. Firm initiated recall is complete. REASON Antihemophilic factor, that may exhibit decreased potency when stored at room temperature, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION Nationwide and Taiwan.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________ PRODUCT a) Hill-Rom bassinet with dropleaf work surface & chart rack; Model 248. Recall # Z-0837-2; b) Hill-Rom Clinical bassinet with dropleaf work surface & chart rack; model 1251. Recall # Z-0838-2. CODE All lot numbers for model 248 and model 1251 bassinets. RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN, by letter dated March 20, 2002. Firm initiated recall is ongoing. REASON Drop leaf work surface may fall down; won't support infant. VOLUME OF PRODUCT IN COMMERCE 6,321 bassinets. DISTRIBUTION Nationwide and Canada, China, England, France, Germany, Honduras, Israel, Japan, Kuwait, Mexico, New Guinea, Panama, Taiwan, Turkey, United Arab Emirates and Uruguay.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT The products are the femoral head implant from the Foundation Hip System. The products are labeled in part: "FOUNDATION***HIP SYSTEM ZIRCONIA FEMORAL HEAD***encore orthopedics". Each femoral head is packaged individually and labeled sterile. Recall # Z-0895-2/Z-0899-2. CODE The Encore lot codes that corresponded to the TH lots from St. Gobain are: Product Number 410-28-000, lot numbers: 427521, 427531, 461661, 462571, 464081, 468051, 468071, 476471, 476481, 510411, 511241, 515071, 518841, 518851, 527891, 527901, 527901A, 540411, 545001, 590221, 590231, 590241, and 590251 Product Number 410-28-035, lot numbers: 516821, 516831, 518841, 518851, 548771, 593021, 627691, 627701, 644001, and 679601 Product Number 410-28-035S, lot numbers: 548631 and 548121 Product Number 410-28-350, lot numbers: 425891, 461681, 468071, 476481, 510431, 515081, 516841, 545011, 548781, 593031, 627711, and 644011 Product Number 410-28-700, lot numbers: 421021, 421031, 425901, 510291, 514991, 518151, 545021, 593041, 597331, and 627721. RECALLING FIRM/MANUFACTURER Encore Orthopedics, Inc., Austin, TX, by telephone on August 16, 2001. Firm initiated recall is ongoing. REASON Femoral head component may fail. VOLUME OF PRODUCT IN COMMERCE 459. DISTRIBUTION Nationwide. _______________________ PRODUCT Covrsite Brand Wound Dressing, Part Numbers 59714100, 59714000 and 59714400. Recall #Z-900-2/Z-902-2. CODE Covrsite (wound dressing): Product Number Lot Number 59714100 0110055 0210055 0310055 0210080 0310080 0410080 01112805 02112805 59714000 0110080 59714400 0110059 0210059. RECALLING FIRM/MANUFACTURER Smith & Nephew, Inc., Largo, FL, by letter on August 28, 2001. Firm initiated recall is complete. REASON Product was a wound dressing not adhering correctly. VOLUME OF PRODUCT IN COMMERCE 215,160 dressings. DISTRIBUTION Nationwide. _______________________ PRODUCT Optetrak Finned Cemented Tibial Tray (Total Knee Joint Replacement-tibial tray component). The device is intended to be implanted during a knee joint replacement surgery. Recall # Z-0903-2/Z-0904-2. CODE Catalog Number 200-04-32, Size 3F/2T, Serial Number Range of 0276096 through 0276125. Catalog Number 200-04-33, Size 3F/3T, Serial Number Range of 0276012 through 0276095. RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL, by letter on November 5, 2001. Firm initiated recall is ongoing. REASON Device packaging may be mislabeled with the wrong size parts. VOLUME OF PRODUCT IN COMMERCE 114. DISTRIBUTION Nationwide and Columbia, Germany, Lebanon, Mexico and Brazil. _______________________ PRODUCT Raptor Rail PTCA Balloon Dilitation Catheter Catalog Numbers RR115, RR215 and RR315. Recall # Z-905-2/Z-907-2. CODE All lot numbers for the following product codes: RR115(1.5mm X 15) RR215(1.5mm X 20) RR315(1.5mm X 30). RECALLING FIRM/MANUFACTURER Cordis Corp., Miami Lakes, FL, by letter on November 9, 2001. Firm initiated recall is ongoing. REASON Some of these catheters had a slower than desired deflation or no deflation. VOLUME OF PRODUCT IN COMMERCE 391 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Exactech Brand Bipolar Hip Prosthesis, intended for use as an endoprosthesis in hemi-hip arthroplasty procedures. a)Catalog # BP-2843, 43 mm OD Bipolar, 28mm ID, Recall # Z-909-2; b)Catalog # BP-2844, 44 mm OD Bipolar, 28mm ID, Recall # Z-910-2. CODE a) S/N 0176015 thru 0176020, S/N 0179203 thru 0179218, S/N 0205170 thru 0205174; b) S/N 0168723 thru 0168735, and S/N 0168822 thru 0168830. RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL, by telephone, fax and letters on December 17, 2001. Firm initiated recall is ongong. REASON The locking ring on the components is potentially assembled backwards. VOLUME OF PRODUCT IN COMMERCE 49. DISTRIBUTION Nationwide. _______________________ PRODUCT Icelock ratchet UX 721, Model L-721000. Recall # Z-0913-2. Designed for use with ICEROSS silicone upper extremity liners for upper extremity amputees. CODE Lots 001,012,021. RECALLING FIRM/MANUFACTURER Recalling Firm: OSSUR North America, Aliso Viejo, CA, by letters on February 27, 2002. Manufacturer: Ossur hf., Iceland. Firm initiated recall is ongoing. REASON Pin does not stay engaged in lock mechanism. VOLUME OF PRODUCT IN COMMERCE 136. DISTRIBUTION Nationwide. _______________________ PRODUCT Misys Laboratory Microbiology Module, Recall # Z-0916-2. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information systems, aka Misys Healthcare, Tucson, AZ. Firm initiated recall is ongoing. REASON Software does not allow comments to be shown in some reports. VOLUME OF PRODUCT IN COMMERCE 735. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2. CODE All units with software version 01-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated March 27, 2002. Manufacturer: Hitachi Ltd., Kbaraki-ken, Japan. Firm initiated recall is ongoing. REASON Possibility of false negative and false positive results being reported. VOLUME OF PRODUCT IN COMMERCE 76. DISTRIBUTION Nationwide. _______________________ PRODUCT Condyle Screw Nut 1 x 05mm. Recall # Z-0927-2. CODE K728316, K766233, K855148, K847887, K957599. RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Allendale, NJ, by letter on December 3, 2001. Manufacturer: Stryker Trauma GmbH D24232 Schoenkirchen, Germany. Firm initiated recall is complete. REASON Torque on the condyle nut onto the condyle screw may be high. As a result the required compression of condyle fragments is not possible. VOLUME OF PRODUCT IN COMMERCE 181. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Gamma Nail System Common Name: Gamma Locking Nail-Cross Locking Screws. Recall # Z-0928-2/Z-0929-2. CODE Catalog Number: 3370-5-030 Lot: K694036 Catalog Number: 3370-5-035 Lot: K694130. RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letters dated October 29, 2001. Stryker Trauma GmbH D24232 Schoenkirchen, Germany. Firm initiated recall is complete. REASON Mislabeling of the screw length on the outer package. VOLUME OF PRODUCT IN COMMERCE 125. DISTRIBUTION Nationwide. _______________________ PRODUCT Total Knee Augnentation Block Implants. Recall # Z-0931-2. CODE All serial numbers with the range of AAAAA-ZZZZZ for the following Part Descriptions and Catalog numbers: Part Description Catalog Number 5mm Tibial Augmentation 1/3 Block Sz.1 204-41-05 8mm Tibial Augmentation 1/3 Block Sz.1 204-41-08 11mm RL,LM Tibial Augmentation 1/3 Block Sz.1 204-41-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.1 204-41-89 5mm Tibial Augmentation 1/3 Block Sz.2 204-42-05 8mm Tibial Augmentation 1/3 Block Sz.2 204-42-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.2 204-42-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.2 204-42-89 5mm Tibial Augmentation 1/3 Block Sz.3 204-43-05 8mm Tibial Augmentation 1/3 Block Sz.3 204-43-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.3 204-43-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.3 204-43-89 5mm Tibial Augmentation 1/3 Block Sz.4 204-44-05 8mm Tibial Augmentation 1/3 Block Sz.4 204-44-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.4 204-44-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.4 204-44-89 5mm Tibial Augmentation 1/3 Block Sz.5 204-45-05 8mm Tibial Augmentation 1/3 Block Sz.5 204-45-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.5 204-45-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.5 204-45-89 1/2 Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05 1/2 Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08 5mm Tibial Augmentation 1/2 Block Sz.1 204-61-05 8mm Tibial Augmentation 1/2 Block Sz.1 204-61-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.1 204-61-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.1 204-61-89 5mm Tibial Augmentation 1/2 Block Sz.2 204-62-05 8mm Tibial Augmentation 1/2 Block Sz.2 204-62-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.2 204-62-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.2 204-62-89 5mm Tibial Augmentation 1/2 Block Sz 3 204-63-05 8mm Tibial Augmentation 1/2 Block Sz 3 204-63-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 3 204-63-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 3 204-63-89 5mm Tibial Augmentation 1/2 Block Sz 4 204-64-05 8mm Tibial Augmentation 1/2 Block Sz 4 204-64-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 4 204-64-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 4 204-64-89 5mm Tibial Augmentation 1/2 Block Sz 5 204-65-05 8mm Tibial Augmentation 1/2 Block Sz 5 204-65-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 5 204-65-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 5 204-65-89 Full Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07 Full Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07 Full Wedge Tibial Augmentation, Size 3 X 20ƒ 204-82-13 Full Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20 Full Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07 Full Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13 Full Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20 Full Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07 Distal 5mm Femoral Aug, Sz. 1 208-05-01 Distal 5mm Femoral Aug, Sz. 2 208-05-02 Distal 5mm Femoral Aug, Sz. 3 208-05-03 Distal 5mm Femoral Aug, Sz. 4 208-05-04 Distal 5mm Femoral Aug, Sz. 5 208-05-05 Distal 10mm Femoral Aug. Sz. 1 208-06-01 Distal 10mm Femoral Aug, Sz. 2 208-06-02 Distal 10mm Femoral Aug, Sz. 3 208-06-03 Distal 10mm Femoral Aug, Sz. 4 208-06-04 Distal 10mm Femoral Aug, Sz. 5 208-06-05 Posterior 5mm Femoral Aug, Sz. 1 208-07-01 Posterior 5mm Femoral Aug, Sz. 2 208-07-02 Posterior 5mm Femoral Aug, Sz. 3 208-07-03 Posterior 5mm Femoral Aug, Sz. 4 208-07-04 Posterior 5mm Femoral Aug, Sz. 5 208-07-05 Posterior 10mm Femoral Aug, Sz. 1 208-08-01 Posterior 10mm Femoral Aug, Sz. 2 208-08-02 Posterior 10mm Femoral Aug, Sz. 3 208-08-03 Posterior 10mm Femoral Aug, Sz. 4 208-08-04 Posterior 10mm Femoral Aug, Sz. 5 208-08-05 5mm Tibial Augmentation 1/3 Block Sz.1 204-41-05 8mm Tibial Augmentation 1/3 Block Sz.1 204-41-08 11mm RL,LM Tibial Augmentation 1/3 Block Sz.1 204-41-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.1 204-41-89 5mm Tibial Augmentation 1/3 Block Sz.2 204-42-05 8mm Tibial Augmentation 1/3 Block Sz.2 204-42-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.2 204-42-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.2 204-42-89 5mm Tibial Augmentation 1/3 Block Sz.3 204-43-05 8mm Tibial Augmentation 1/3 Block Sz.3 204-43-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.3 204-43-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.3 204-43-89 5mm Tibial Augmentation 1/3 Block Sz.4 204-44-05 8mm Tibial Augmentation 1/3 Block Sz.4 204-44-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.4 204-44-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.4 204-44-89 5mm Tibial Augmentation 1/3 Block Sz.5 204-45-05 8mm Tibial Augmentation 1/3 Block Sz.5 204-45-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.5 204-45-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.5 204-45-89 1/2 Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05 1/2 Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08 5mm Tibial Augmentation 1/2 Block Sz.1 204-61-05 8mm Tibial Augmentation 1/2 Block Sz.1 204-61-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.1 204-61-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.1 204-61-89 5mm Tibial Augmentation 1/2 Block Sz.2 204-62-05 8mm Tibial Augmentation 1/2 Block Sz.2 204-62-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.2 204-62-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.2 204-62-89 5mm Tibial Augmentation 1/2 Block Sz 3 204-63-05 8mm Tibial Augmentation 1/2 Block Sz 3 204-63-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 3 204-63-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 3 204-63-89 5mm Tibial Augmentation 1/2 Block Sz 4 204-64-05 8mm Tibial Augmentation 1/2 Block Sz 4 204-64-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 4 204-64-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 4 204-64-89 5mm Tibial Augmentation 1/2 Block Sz 5 204-65-05 8mm Tibial Augmentation 1/2 Block Sz 5 204-65-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 5 204-65-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 5 204-65-89 Full Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07 Full Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07 Full Wedge Tibial Augmentation, Size 3 X 20ƒ 204-82-13 Full Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20 Full Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07 Full Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13 Full Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20 Full Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07 Distal 5mm Femoral Aug, Sz. 1 208-05-01 Distal 5mm Femoral Aug, Sz. 2 208-05-02 Distal 5mm Femoral Aug, Sz. 3 208-05-03 Distal 5mm Femoral Aug, Sz. 4 208-05-04 Distal 5mm Femoral Aug, Sz. 5 208-05-05 Distal 10mm Femoral Aug. Sz. 1 208-06-01 Distal 10mm Femoral Aug, Sz. 2 208-06-02 Distal 10mm Femoral Aug, Sz. 3 208-06-03 Distal 10mm Femoral Aug, Sz. 4 208-06-04 Distal 10mm Femoral Aug, Sz. 5 208-06-05 Posterior 5mm Femoral Aug, Sz. 1 208-07-01 Posterior 5mm Femoral Aug, Sz. 2 208-07-02 Posterior 5mm Femoral Aug, Sz. 3 208-07-03 Posterior 5mm Femoral Aug, Sz. 4 208-07-04 Posterior 5mm Femoral Aug, Sz. 5 208-07-05 Posterior 10mm Femoral Aug, Sz. 1 208-08-01 Posterior 10mm Femoral Aug, Sz. 2 208-08-02 Posterior 10mm Femoral Aug, Sz. 3 208-08-03 Posterior 10mm Femoral Aug, Sz. 4 208-08-04 Posterior 10mm Femoral Aug, Sz. 5 208-08-05. RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL, by telephone and letters on May 21, 2001. Firm initiated recall is complete. REASON Compromise of sterility barrier packaging. VOLUME OF PRODUCT IN COMMERCE 1723. DISTRIBUTION Nationwide. _______________________ PRODUCT Laser Guard Endotracheal Tube Protector. Recall # Z-0932-2. CODE Catalog 400446, lot number 22853900. RECALLING FIRM/MANUFACTURER Medtronic Xomed Jacksonville, FL, by telephone and fax August 30, 2001. Firm initiated recall is ongoing. REASON The Endotracheal Tube Silver Foil wrap may develop breaks when manipulated. Potential for overheating or fire. VOLUME OF PRODUCT IN COMMERCE 20. DISTRIBUTION AK, CO and LA and Italy. _______________________ PRODUCT Cida-Steryl 28 II 3% Glutaraldehyde. Recall # Z-0935-2. CODE Lots L062701, L063001, L052111, L052211 and L042311. RECALLING FIRM/MANUFACTURER Ecolab Inc., Huntington, IN, by letter dated January 17, 2002. Firm initiated recall is ongoing. REASON May not effectively sterilize devices. VOLUME OF PRODUCT IN COMMERCE Approx 700 cases of 4 quarts or 4 gallons each. DISTRIBUTION Nationwide. _______________________ PRODUCT BX Velocity Balloon Expandable Stent, (common name is Coronary Stent and Delivery System, 8mm X 2.75, Sterile. Recall #Z-0936-2. CODE Catalog Number VW08275, lot number 40401536. RECALLING FIRM/MANUFACTURER Cordis Corp., Miami Lakes, FL, by letter on December 7, 2001. Firm initiated recall is ongoing. REASON Stents could migrate from their original crimped position on the the delivery system. VOLUME OF PRODUCT IN COMMERCE 91. DISTRIBUTION Nationwide. _______________________ PRODUCT BioZ.com Hemodynamic Monitor Impedance Plethysmograph. Recall # Z- 0937/Z-0938. CODE All codes. RECALLING FIRM/MANUFACTURER Cardiodynamics International Corp., San Diego, CA, by letter the week of January 14, 2002. Firm initiated recall is complete. REASON Improper responses with pacemaker patients. VOLUME OF PRODUCT IN COMMERCE 27. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Video Bronchoscope, Model EB-1530T3, Device Listing #A845585. Classification: EOQ, Bronchoscope, CFR 874.4680. Recall # Z-0939-2; b) Video Gastroscope, Model #EG-1540, Device Listing #A845591. Classification: FDS, Gastroscope, CFR 876.1500. Recall # Z-0940-2. c) Video Esophagoscope, Model #EE-1540, Device Listing #A845597. Classification: GCL, Esophagoscope, CFR 876.1500. Recall # Z-0941-2. CODE a) (333 units): Serial Numbers: A01001, A01005, A01011, A01014, A01015, A01017, A01018, A01022, A01024, A01037, A01038, A01039, A01040, A01043, A01047, A01048, A01049, A01050, A01051, A01053, A01054, A01055, A01056, A01057, A01058, A01059, A01061, A01063, A01069, A01070, A01071, A01072, A01073, A01074, A01075, A01076, A01077, A01078, A01079, A01080, A01081, A01084, A01087, A01099, A01102, A01103, A01104, A01109, A01111, A01112, A01115, A01116, A01117, A01121, A01122, A01123, A01124, A01125, A01126, A01128, A01129, A01130, A01131, A01135, A01137, A01139, A01140, A01142, A01143, A01144, A01145, A01147, A01148, A01149, A01151, A01152, A01153, A01155, A01157, A01158, A01159, A01162, A01166, A01167, A01169, A01170, A01171, A01172, A01173, A01175, A01176, A01178, A01179, A01180, A01181, A01183, A01188, A01192, A01197, A01202, A01207, A01208, A01209, A01210, A01213, A01215, A01220, A01222, A01225, A01227, A01228, A01230, A01231, A01232, A01242, E01243, E01244, E01245, E01246, E01247, E01248, E01251, E01253, E01254, E01255, E01259, E01260, E01261, E01262, E01263, E01264, E01265, E01268, E01270, E01271, E01273, E01275, E01279, E01280, E01282, E01283, E01285, E01286, E01288, E01296, E01298, E01305, E01306, E01308, E01309, E01312, E01314, E01315, E01316, E01318, E01321, E01322, E01323, E01327, E01329, E01332, E01334, E01335, E01336, E01337, E01338, E01339, E01340, E01341, E01343, E01344, E110465, E110466, E110467, E110468, E110469, E110470, E110471, E110472, E110473, E110474, E110476, E110477, E110478, E110481, E110482, E110483, E110484, E110485, E110490, E110491, E110492, E110493, E110494, E110496, E110500, E110501, E110502, E110503, E110504, E110505, E110506, E110508, E110510, E110512, E110519, E110520, E110521, E110522, E110523, E110524, E110525, E110528, E110534, E110535, E110539, E110540, E110541, E110544, E110545, E110546, E110548, E110549, E110552, E110553, E110557, E110559, E110560, E110561, E110565, E110566, E110567, E110568, E110569, E110571, E110572, E110573, E110574, E110575, E110576, E110577, E110578, E110579, E110580, E110581, E110582, E110590, E110591, E110592, E110593, E110594, E110595, E110596, E110597, E110599, E110600, E110603, E110604, E110606, E110608, E110609, E110610, E110611, E110613, E110617, E110619, E110620, E110626, E110633, E11346, E11347, E11348, E11349, E11350, E11352, E11353, E11354, E11356, E11357, E11361, E11364, E11374, E11380, E11382, E11383, E11387, E11388, E11389, E11390, E11391, E11392, E11394, E11396, E11397, E11398, E11399, E11401, E11403, E11404, E11405, E11406, E11407, E11408, E11409, E11410, E11411, E11412, E11413, E11429, E11430, E11431, E11432, E11433, E11434, E11435, E11439, E11442, E11443, E11448, E11450, E11451, E11452, E11453, E11454, E11456, E11457, E11458, E11459, E11460, E11461, E11462, E11463, E11464. b) (24 units): Serial Numbers: A01003, E010013, E010014, E010015, E010016, E010017, E010019, E010020, E010022, E010026, E010027, E010029, E010031, E010034, E010037, E010038, E010039, E010041, E010042, E010047, E010048, E010049, E010051, E010056. c) (24 units): Serial Numbers: A01001, A01006, E010011, E010012, E010014, E010015, E010016, E010019, E010020, E010021, E010022, E010023, E010027, E010028, E010029, E010030, E010031, E010033, E010034, E010037, E010038, E010039, E010040, E010041. RECALLING FIRM/MANUFACTURER Recalling Firm: Pentax Precision Instrument Corp., Orangeburg, NY, by letters dated March 14, 2002. Firm initiated recall is ongoing. REASON Lubricant leaking from bronchoscope caused by puncture at the point where the instrument channel is secured to the distal end. VOLUME OF PRODUCT IN COMMERCE a) 333 units; b) 24 units; c) 24 units. DISTRIBUTION Nationwide and Canada, Chile, Brazil and Guam. _______________________ PRODUCT Recall # Z-0942-2/Z-0946-2. a) Hill-Rom brand TranStar Electric Stretcher; b) Hill-Rom brand TranStar OB/GYN Stretcher; c) Hill-Rom brand TranStar Procedural Stretcher; d) Hill-Rom brand TranStar Surgical Stretcher; e) Hill-Rom brand TranStar Trauma Stretcher; f) Hill-Rom brand Durastar Hydraulic Stretcher. CODE All units distributed prior to March 1, 2002. RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN, by letter dated April 2002. Firm initiated recall is ongoing. REASON May leak hydraulic fluid. VOLUME OF PRODUCT IN COMMERCE 38,770 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Hill-Rom Exam Plus lights, catalog numbers P965-00 and P965-01. Recall # Z-0947-2/Z-0948-2. CODE All units RECALLING FIRM/MANUFACTURER Hill-Rom Co. Inc., Batesville, IN, by letter on April 8, 2002. Firm initiated recall is ongoing. REASON Incorrectly labeled for use during surgical procedures. VOLUME OF PRODUCT IN COMMERCE 9451 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Double Port Flow Adapter, STERIS Part Number 200388. Recall # Z-0949-2. 1) Sold as a component of STERIS Quick Connect Kit #C1460; 2) Also sold individually as a replacement component. CODE Part Number 200388. RECALLING FIRM/MANUFACTURER Steris Corp., Mentor, OH, by telephone on March 19 and 20 and by letter on March 21, 2002. Firm initiated recall is ongoing. REASON Adapter ports may be obstructed with glue, and affect the sterilization process. VOLUME OF PRODUCT IN COMMERCE 83. DISTRIBUTION Nationwide and Canada, New Zealand, Great Britain and Italy. _______________________ PRODUCT Omni-Diagnost X-Ray System, fluoroscopic x-ray system: multifunctional, universal, overtable x-ray system offering fluroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. Recall # Z-0959-2. CODE p/n 9896 000 59551 shipped before 11/01. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated March 29, 2002. Firm initiated recall is ongoing. REASON The scan carriage may collide with the patient's knees. VOLUME OF PRODUCT IN COMMERCE 25. DISTRIBUTION Nationwide. _______________________ PRODUCT All DataCare Systems Software, as follows: Recall # Z-0960-2/Z-0974-2. a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200; b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201; c) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9251; d) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252; e) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9200; f) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201; g) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9206; h) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9207; i) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9208; j) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9251; k) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9252; l) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202; m) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209; n) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9010; o) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211; p) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212 q) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9215; r) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216. CODE All units. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by urgent product correction dated April 15, 2002. Firm initiated recall is ongoing. REASON Potential patient/sample mismatch. VOLUME OF PRODUCT IN COMMERCE Approx. 512 installations. DISTRIBUTION Nationwide, the United Kingdom and Canada. _______________________ PRODUCT CryoValve Allograft. Recall # Z-0981-2. CODE Serial No. 6083099, Model No. PV00. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on April 1, 2002. Firm initiated recall is complete. REASON Serodilution of plasma. VOLUME OF PRODUCT IN COMMERCE One. DISTRIBUTION OK. ______________________ PRODUCT Steel Oxygen Wrench. The device is a Class I steel oxygen wrench. a) Catalog number 169 has a security wire attached to the wrench. b) Catalog number 169W does not have the wire. Recall # Z-0982-2/Z-0983-2. CODE a) Lot number P0110502; b) Lot numbers P1101701 and P0100602. RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Industries, Inc., Bethel Park, PA, by telephone and letters on March 22, 2002. Manufacturer: MK Manufacturing Forestville, CT. Firm initiated recall is ongoing. REASON Slots may not be big enough to fit on E tanks. VOLUME OF PRODUCT IN COMMERCE 265. DISTRIBUTION CA, LA, MT, NC, NM, PA, WI and Canada _______________________ PRODUCT CryoValve Allograft - Heart Valve. Recall # Z-0984-2. CODE Serial No. 3887073, Model Number PV00. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by telephone on April 8, 2002. Firm initiated recall is complete. REASON Serodilution of Plasma. VOLUME OF PRODUCT IN COMMERCE One. DISTRIBUTION OH.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Brand Name: Walgreens Sterile Insulin syringes, single use, disposable, 0.3cc and 1.0cc 29 Gauge. Recall # Z-0911-2/Z-0912-2. CODE Description: Corrugated case: 3/10cc 29G Walgreens brand syringes Catalog No. 677257 Lot Code: 7688 Description: Boxes, identified 1cc 29G Walgreens brand syringes Catalog No: 677259 Lot Code: 7688. RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co. Franklin Lakes, NJ, by e-mail on January 11, 2002. Manufacturer: Boin Medica Co., Inc, Kumi City, Kyungbuk, Korea. Firm initiated recall is ongoing. REASON Mispackaged syringes; 3/30cc syringes into 1.0cc syringe boxes. VOLUME OF PRODUCT IN COMMERCE 2,460 boxes. DISTRIBUTION PA, FL, WI, IL and TX. _______________________ PRODUCT Gyroscan NT System, MRI. Recall # Z-0917-2. CODE p/n: 9896 030 0660, 9896 030 0645, 9896 030 0527, 9896 030 0511, 9896 030 0461. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America Company, Bothell, WA, by communication on December 4, 2001. Manufacturer: Philips Medical Systems Nederland, B.V. Netherlands. Firm initiated recall is ongoing. REASON Potential for misdiagnosis. When two images were subtracted, one with contrast and the other without contrast, irregular vessels could be the result on the final image. VOLUME OF PRODUCT IN COMMERCE 220. DISTRIBUTION Nationwide. _______________________ PRODUCT Integris H5000, Angiographic X-ray system. Recall # Z-0924-2. CODE Units with SYSCO software version 11.1.2. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001., Manufacturer: Philips Medical Systems Nederland, b.v 5680 Da Best, Netherlands. Firm initiated recall is ongoing. REASON System may occasionally re-boot during a patient examination. VOLUME OF PRODUCT IN COMMERCE 171. DISTRIBUTION Nationwide. _______________________ PRODUCT LightCycler v1.0; catalog # 2011468. Recall # Z-0925-2 LightCycler v1.1; catalog # 2043912. Recall # Z-0926-2. The device is a medium-sized polymerase chain reaction analyzer for use in industrial, laboratory and domestic setting. CODE All units. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 5, 2002. Manufacturer: Roche Diagnostics Corp., Mannheim, Germany. Firm initiated recall is ongoing. REASON Glass capillary breakage. VOLUME OF PRODUCT IN COMMERCE 190. DISTRIBUTION Nationwide. _______________________ PRODUCT Hydroview brand Intraocular Lens, Posterior chamber lenses, various diopters. Recall # Z-0933-2. CODE Model Number H60M, Lot Numbers 5YXP and 6R4B. RECALLING FIRM/MANUFACTURER Bausch & Lomb Surgical, Inc., Clearwater, FL, by letter beginning August 31, 2001. Firm initiated recall is ongoing. REASON Lenses were labeled with incorrect dioptic powers. VOLUME OF PRODUCT IN COMMERCE 17. DISTRIBUTION Japan, France and Great Britain. _______________________ PRODUCT MacroPore NS CraniLoc Burr Hole Clamp. This is a part of the CraniLoc Cranial Flap Fixation System. Catalog Number: 6692599. Recall # Z-0934-2. CODE Lots 51715, 51716, 51717, and 51782. RECALLING FIRM/MANUFACTURER Macropore, Inc., San Diego, CA, by letter on December 7, 2001. Firm initiated recall is ongoing. REASON Loosening and breakage. VOLUME OF PRODUCT IN COMMERCE 1400. DISTRIBUTION Nationwide and the Netherlands. _______________________ PRODUCT GYROSCAN NT SYSTEM, MRI - Magnetic Resonance Systems. Recall # Z-0955-2. CODE p/n 9896 030 00901, 9896 030 00902, 9896 030 00911, 9896 030 00912. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America Company, Bothell, WA, by Field Change Order dated September 2001. Manufacturer: Phillips Medical Systems Nederland, B.V. 5680 DA BEST, Netherlands. Firm initiated recall is ongoing. REASON Potential for tabletop (bed) to slide. VOLUME OF PRODUCT IN COMMERCE 17. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Polarus Humeral Rod, part #HRH-0824-S, 8mm x 240mm. Recall # Z-0978-2. b) Polarus Humeral Rod, part #HRH-0826-S, 8mm x 260mm. Recall # /Z-0979-2. These implants belong to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. CODE a) lot W04193 b) lot W04194. RECALLING FIRM/MANUFACTURER Acumed, Inc., Hillsboro, OR, by fax, e-mail or letter on March 7, 2002. Firm initiated recall is complete. REASON Mislabeled - 240mm Polarus rod labeled as 260mm Polarus rod & vice versa. VOLUME OF PRODUCT IN COMMERCE Two units of each size. DISTRIBUTION Puerto Rico. ______________________ PRODUCT Precision UV (ultraviolet blocking) daily or extended wear soft (hydrophilic) contact lens. Recall # Z-0980-2. CODE Lot Number 31648106, exp. date 2005/09 Lot Number 31682132, exp. date 2005/10. RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA, by telephone on April 4, 2002. Manufacturer: Ciba Vision Batam Pulau Batam, Indonesia. Firm initiated recall is ongoing. REASON Product was distributed without the proper labeling. VOLUME OF PRODUCT IN COMMERCE 82 three-packs. DISTRIBUTION Nationwide and Puerto Rico.END OF ENFORCEMENT REPORT FOR MAY 1, 2002 ####
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2002-MAY-02.