November 6, 2002 02-44
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_____________________________ PRODUCT Coconut Jelly candies with Konjac/Konnyaku, packaged under the following brands: a) JM Jojomo Nata De Coco Konnyaku Jelly, Jojomo Enterprise Co., Ltd., No. 40, Min Hua Lane, Fu An Village, Hsiushui Hsiang, Changhua Hsien, Taiwan: JM Jojomo Lychee Flavor Nata De Coco Konnyaku Jelly in 8.8 oz. bags, UPC #719361-000067 and 1500 g plastic jars. Recall # F-037-3; JM Jojomo Mango Flavor Nata De Coco Konnyaku Jelly in 8.8 oz. bags and 1500 g plastic jars. Recall # F-038-3; JM Jojomo Mixed Flavors Nata De Coco Konnyaku Jelly in 1500 g plastic jars. Recall # F-039-3; Jojomo Peach Flavor Nata De Coco Konnyaku Jelly in 1500 g plastic jars. Recall # F-040-3; JM Jojomo Durian Flavor Nata De Coco Konnyaku Jelly in 1500 g plastic jars. Recall # F-041-3; b) Naluwan Nata De Coco Konnyaky Jelly, Lien Hoa Food Corp., Chicago, IL USA and Hong Thai Foods Corp., Brooklyn, NY: Naluwan Mixed Flavors Nata De Coco Konnyaku Jelly in 8.8 oz. bags, UPC #717016-050085. Recall # F-042-3. The product is packaged in individual serving sized plastic cups with foil lids, with the product meant to be squeezed out of the cup directly into the mouth. The 16.5-17 gram individual serving cups are packaged in 8.8 oz. (250 gram) plastic bags/30 bags per case and 1500 gram round plastic jars/6 jars per case. CODE All lots of all flavors of the Jojomo and Naluwan labeled product. RECALLING FIRM/MANUFACTURER Recalling Firm: Lien Hoa Food Corp., Chicago, IL, by letters dated March 6, 2002. Manufacturer: Jojomo Enterprise Co., Ltd., Changhua Hsien, TW. Firm initiated recall is complete. REASON This candy is in violation of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard. VOLUME OF PRODUCT IN COMMERCE 464 cases. DISTRIBUTION IL and WI. _____________________________ PRODUCT Mini Fruit Jelly snack cups, Brand ABC NATA DECOCO, various and assorted flavors. Sold in 10.5 oz bag and plastic jar containing about 105 cups. Varieties included: a) Assorted. Recall # F-043-3; b) Mango. Recall # F-044-3; c) Peach. Recall # F-045-3; d) Lychee. Recall # F-046-3. CODE All codes. RECALLING FIRM/MANUFACTURER Recalling Firm: Fresco World, Inc., Los Angeles, CA, by letter dated August 6, 2002 and by press release on August 8, 2002. Manufacturer: Tsang Lin Industries Ltd., Taichung, Taiwan. Firm initiated recall is complete. REASON This candy is in violation of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard. VOLUME OF PRODUCT IN COMMERCE 41,269 cases. DISTRIBUTION CA, NY and Mexico. _____________________________ PRODUCT GOLD NOSH brand Dried Cantaloupe, packed in rigid plastic containers, net wt. 7 oz. ING: Cantaloupe, Sugar. Recall # F-048-3. CODE Barcode # 44664 00202. RECALLING FIRM/MANUFACTURER Gold Nut Corporation DBA Gold Nosh Co., Brooklyn, NY, by telephone on February 4, 2002. State initiated recall is complete. REASON The product contained undeclared sulfites (166 ppm). VOLUME OF PRODUCT IN COMMERCE Approx. 120 - 7 oz. containers. DISTRIBUTION NY. _____________________________ PRODUCT Liquid Egg Whites, 11,200 lbs. Recall # F-049-3. The production lot was stored in the following containers: Three 1,800 pound Zero tanks (numbers 89-112-125); One 2,200 pound square tank (number 16-A); One hundred twenty 30 pound frozen plastic buckets. CODE Lot 2112. RECALLING FIRM/MANUFACTURER Hi-Point Industries, Los Angeles, CA, by fax and telephone on August 6, 2002. Firm initiated recall is complete. REASON Salmonella. VOLUME OF PRODUCT IN COMMERCE 7600 lbs. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_____________________________ PRODUCT Hall of Fame Brand Cool-Refreshing Mints Artificially Flavored, Net Wt. 6 OZS., packed in flexible plastic packages. Recall # F-036-3. CODE Barcode: 42726 00241; Code: 0071101 RECALLING FIRM/MANUFACTURER Horizon Merchandising Inc. DBA Hall Of Fame Candy & Nuts, INC., Brooklyn, NY, by telephone on September 5, 2001. State initiated recall is complete. REASON The product contained undeclared colors - FD&C Yellow #5, Yellow #6, and Blue #1. VOLUME OF PRODUCT IN COMMERCE 100 - 6 oz. Packages. DISTRIBUTION NY.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_____________________________ PRODUCT Plasdone K-29/32 (Povidone, USP/Ph.Eur. K-30), 110 lb drums. Recall # D- 045-3. CODE Lot 0500035188 and 0500035268. RECALLING FIRM/MANUFACTURER Recalling Firm: International Specialty Products, Wayne, NJ, by letters dated November 27, 2000. Manufacturer: ISP Technologies, Texas City, TX. Firm initiated recall is ongoing. REASON Product contains metal particles VOLUME OF PRODUCT IN COMMERCE Lot 05000035188: 24,200 lbs; Lot 05000035268, 13,310 lbs. DISTRIBUTION OH, DE, IL, MI, PA, VA, NY, ME and Internationally. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II _____________________________ PRODUCT Red Blood Cells. Recall # B-0078-3. CODE Unit GQ22080. RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by telephone on July 8, 2002. Firm initiated recall is complete. REASON Blood product, that was collected from a donor in which the hemoglobin or hematocrit was not recorded on the donor record, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________________ PRODUCT a) Red Blood Cells, Leukoreduced. Recall # B-0082-3; b) Recovered Plasma, Recall # B-0083-3. CODE a) and b) Unit 10733-2286. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 1, 2002 or by letter dated July 24, 2002. Manufacturer: United Blood Services, Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ and Germany. _____________________________ PRODUCT Platelet, Pheresis, Leukoreduced. Recall # B-0084-3. CODE Unit LZ08659 RECALLING FIRM/MANUFACTURER Recalling Firm: United Blood Services, Scottsdale, AZ, by telephone on July 27, 2002. Manufacturer: Tri- Counties Blood Bank, Santa Barbara, CA. Firm initiated recall is complete. REASON Blood product, for which documentation of irradiation was incomplete, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________________ PRODUCT Tibialis Tendon Allograft, Recall # B-0085-3. CODE Model Number T080, Serial Numbers 7840453, 7840496 and 7849215. RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA, by letter dated October 1, 2002. Firm initiated recall is ongoing. REASON Tissues for transplant were collected from a donor who had not been properly evaluated. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION AZ and Canada. _____________________________ PRODUCT Recovered Plasma, Recall # B-0086-3. CODE Unit 1848869. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 6, 2002. Firm initiated recall is complete. REASON Blood product, which was manufactured in a manner that compromised the sterility of the collection system, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0087-3; b) Fresh Frozen Plasma, Recall # B-0088-3. CODE a) and b) Unit number 10718-4551. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated August 13, 2002. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0089-3. CODE Unit number 10730-3467 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated August 13, 2002. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. 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 NV. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0090-3. CODE Unit number 10733-1892. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 12, 2002 and by letter dated July 30, 2002. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _____________________________ PRODUCT Recovered Plasma. Recall # B-0091-3. CODE Unit number 53GV42984. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on September 6, 2001. Firm initiated recall is complete. REASON Blood product, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was collected from a donor that subsequently reported a previous reactive test for anti-HIV, was distributed. VOLUME OFPRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall # B-0092-3. CODE Unit numbers 10718-6929, 10722-3664, and 10727-9388; the following units were distributed as two split products: unit numbers 10724-6779, 10725- 9726, and 10727-3762. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated July 31, 2002. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Plavix, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION AZ. _____________________________ PRODUCT Platelets. Recall # B-0093-3. CODE Unit numbers 10733-6925, 10733-6926, 10733-6931, and 10733-6936. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 24, 2002. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, manufactured from units of Whole Blood possibly exposed to incorrect shipping temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION AZ. _____________________________ PRODUCT a) Red Blood Cells. Leukocytes Reduced, Recall # B-0094-3; b) Fresh Frozen Plasma. Recall # B-0095-3. CODE a) and b) Unit number 10705-6239. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 9, 2001 and by letter dated October 30, 2001. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _____________________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0096-3; b) Fresh Frozen Plasma, Recall # B-0097-3; c) Cryoprecipitate, Recall # B-0098-3; d) Plasma, Recall # B-0099-3. CODE a) Unit 12V32424; b) Unit 12V32424, 12Y31815, 12X99508; c) Unit 12E25643; d) Unit 12E25643. RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Regional Blood Services, Charlotte, NC, by telephone on July 15, 2002 and by letter dated July 25, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION NC. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0100-3; b) Recovered Plasma. Recall # B-0101-3. CODE a) and b) Unit numbers 27GL24114 and 27S55017. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on June 27, 2002 and by letter on July 2, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA, WV and OH. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0102-3; b) Recovered Plasma. Recall # B-0103-3. CODE a) and b) Unit number 27GH06764. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone and letter on June 25, 2002. 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 CA and WV. _____________________________ PRODUCT Recovered Plasma, Recall # B-0104-3. CODE Unit numbers 27FR08996, 48G89326, and 48N30152 RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by fax on May 29, 2002. 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 3 units. DISTRIBUTION CA. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0105-3. CODE Unit numbers 33GF44411 and 33GF44395. RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on May 23, 2002. Firm initiated recall is complete. REASON Blood products, corresponding to units of Platelets that were pooled and were possibly contaminated with Streptococcus sp. bacteria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CT. _____________________________ PRODUCT a) Red Blood Cells, Recall # B-0135-3; b) Platelets Irradiated, Recall # B-0136-3. CODE a) and b) Unit number L07618. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated May 28, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA. _____________________________ PRODUCT a) Red Blood Cells, Recall # B-0137-3; b) Red Blood Cells. Leukocytes Reduced, Recall # B-0138-3. c) Platelets. Recall # B-0139-3. CODE a) Unit number S07293; b) Unit number L34688; c) Unit numbers S07293 and L34688. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated June 6, 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 4 units. DISTRIBUTION VA. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0140-3; b) Platelets Irradiated. Recall # B-0141-3. CODE a) and b) Unit number L61977. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letters dated December 10, 2001 and January 7, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA. _____________________________ PRODUCT Red Blood Cells. Recall # B-0142-3. CODE Unit number C80015. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on July 26, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _____________________________ PRODUCT Red Blood Cells. Recall # B-0143-3. CODE Unit number R64420. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on July 26, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _____________________________ PRODUCT Source Plasma. Recall # B-0144-3. CODE Unit numbers SC897207, SC904860, SC905211, SC905377, SC905738, SC905954, SC906759, SC907012, SC907147, SC907361, SC907478, SC907767, SC908252, SC908442, SC908983, SC909193, 06531379, 06536787, 06384685, 08645685, 08702913, 08706515, 08709080, SC909939, 09143388, and 06543167. RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., State College, PA, by letter on March 23, 1999. Firm initiated recall is complete. REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 26 units. DISTRIBUTION CA, NY and Germany. _____________________________ PRODUCT Source Plasma. Recall # B-0145-3. CODE Unit numbers SH936655, SH937019, SH937311, SH938224, SH938616, and SH938911 RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Harrisburg, PA, by letter on June 5, 1998. Firm initiated recall is complete. REASON Blood products, that tested negative for antibodies 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 6 units. DISTRIBUTION CA and Germany. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III _____________________________ PRODUCT Fresh Frozen Plasma. Recall # B-0081-3. CODE Unit 10724-0644. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 24, 2002 and by letter dated July 24, 2002. Manufacturer: United Blood Services, Scottsdale, AZ. Firm initiated recall is complete. REASON Blood product, which was incorrectly labeled as Fresh Frozen Plasma, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _____________________________ PRODUCT Fresh Frozen Plasma. Recall # B-0106-3. CODE Unit numbers 27GT73556, 27GT73572, 27LG49833, 27LH02907, 27GJ19910, 27GM65965, 27GS56020, 27GS56025, 27GS56026, 27LJ28578, 27LJ28668, 27LJ28707, 27GC74609, 27GM65868, 27GX49888, 27LH02996, 27GX49890, 27GC74614, 27GC74618, 27GC74629, 27GM65878, 27GM65885, 27LG49933, 27LG49934, 27LH02988, 27LJ28666, 27GM66421, 27GS56419, 27GS55729, 27GS55735, 27LH02852, 27LP00259, 27GC74519, 27GM65694, 27GS55730, 27GY48917, 27GM65967, 27GS56027, 27GY49120, 27GY49125, 27LG49962, 27LJ28647, 27LJ28698, 27GM66501, 27GM65680, 27GT73357, 27GL35050, 27GL35054, 27GL35061, 27GL35077, 27GL35082, 27GT73331, 27GT73376, 27GT73379, 27GT73395, 27GX49656, 27LH02972, 27GC74613, 27GM65890, 27LH02986, 27LM14681, 27GC74671, 27GC74674, 27GM66008, 27LM14526, 27GT73332, 27GX49652, 27GL35546, 27GM66399, 27GM66413, 27GT74232, 27GM66481, 27GM66562, 27GM66573, 27GM66589, 27GM66590, 27GS56472, 27GS56479, 27GT74230, 27GX50306, 27LG50269, 27LM14858, 27GC74533, 27GC74547, 27GM65676, 27GM65790, 27GM65802, 27GT73381, 27GT73384, 27LG49771, 27LG49778, 27LP00255, 27LP00267, 27GJ19850, 27GJ19852, 27GM65826, 27GM65877, 27GS55870, 27LG49876, 27LG49889, 27LG49932, 27N41221, 27N41222, 27N41223, 27N41228, 27N41230, 27N41233, 27N41234, 27N41237, 27GC74603, 27GJ19880, 27GJ19881, 27GJ19883, 27GJ19885, 27GJ19888, 27GJ19895, 27GJ19896, 27GS56006, 27GS56007, 27LC24520, 27LJ28642, 27LJ28643, 27LJ28665, 27LJ28761, 27LM14666, 27GM66388, and 27GX50287. RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter on July 18, 2002. Firm initiated recall is complete. REASON Blood products, stored at an incorrect temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 127 units. DISTRIBUTION PA, OH and WV. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0107-3. CODE Unit numbers 1164519 and 1164840. RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letters on July 9 and 18, 2001. REASON Blood products, collected from donors whose arm inspection were not documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _____________________________ PRODUCT Red Blood Cells. Recall # B-0108-3. CODE Unit number C80012. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on June 28, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was noted to be unacceptable, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0109-3; b) Platelets. Recall # B-0110-3. CODE a) and b) Unit number L80246. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on July 1, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm inspection was noted to be unacceptable, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA. _____________________________ PRODUCT Platelets. Recall # B-0111-3. CODE Unit number L10322. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on July 26, 2002. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _____________________________ PRODUCT Red Blood Cells. Recall # B-0146-3. CODE Unit numbers R43377, R43808, and R44384. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on July 26, 2002. Firm initiated recall is complete. REASON Blood products, that exceeded the firm's maximum specification for red blood cell volume, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION VA. _____________________________ PRODUCT Platelets, Irradiated. Recall # B-0147-3. CODE Unit number M73894. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter on August 19, 2002. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to a history of ulcerative colitis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _____________________________ PRODUCT Collagenase Santyl? Ointment. Recall # B-0148-3. CODE Lot numbers 0000093137, 0000096499, 0000034432, 0000045979, and 3490 1077. RECALLING FIRM/MANUFACTURER Advance Biofactures Corporation, Lynbrook, NY, by letter on or about October 25, 2002. Firm initiated recall is complete. REASON Product was found to have decreased potency throughout the dating period. VOLUME OF PRODUCT IN COMMERCE 5 lots. DISTRIBUTION NJ and FL. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II _____________________________ PRODUCT a) IntraStent DoubleStrut ParaMount, Premounted Biliary Stent System; b) Protégé Self Expanding Nitinol Stent, Biliary System. c) IntraStent DoubleStrut ParaMount XS Premounted Biliary Stent System. Recall # Z-0153-3. CODE a) Model Number SPM16-26-05-B, Lot Number MF2892; Model Number SPM16-26-07-B, Lot Numbers MF2964, MF3952, and MF2966; Model Number SPM16-26-08-B, Lot Number MF2965; Model Number SPM16-16-05-B, Lot Numbers MF2967, MF4236, MF2893, and MF4191; Model Number SPM16-36-08-B, Lot Number MF2973. b) Model Number SE7-9-20-80, Lot Numbers MF2935 and MF3803; Model Number SE7-7-60-120, Lot Number MF2941; Model Number SE7-9-20-120, Lot Numbers MF2942, MF3473, MF3747 and MF4135; Model Number SE7-6-40-120, Lot Numbers MF2940 and MF3296; Model Number SE7-7-40-80, Lot Numbers MF2950 and MF3805. c) Model Number SPM14-12-07-B, Lot Number MF3056. RECALLING FIRM/MANUFACTURER Sulzer IntraTherapeutics Inc., St. Paul, MN, by letter on October 9, 2002. Firm initiated recall is ongoing. REASON Some of the pouches for maintaining device sterility were unsealed. VOLUME OF PRODUCT IN COMMERCE 350 units. DISTRIBUTION Nationwide and Brazil, France, Greece, Italy and Taiwan. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III _____________________________ PRODUCT EBV-VCA IgG ELISA and EBV-VCA IgM ELISA, diagnostic test kits, packaged under the Meridian Bioscience label. These kits are: a) Epstein-Barr Virus (EBV) IgM. Recall # Z-0141-3; b) IgG Viral-Capsid-Antigen (VCA) Test Systems. Recall # Z-0142-3. CODE Description Catalog No. Lot No. EBV-VCA IgM 626096 01012519 EBV-VCA IgG 624096 02017062 and 02017063. RECALLING FIRM/MANUFACTURER Recalling Firm: Meridian Bioscience, Inc., Cincinnati, OH, by letters dated December 31, 2001 and July 2, 2002. Manufacturer: Zeus Scientific, Inc., Branchburg, NJ. Firm initiated recall is ongoing. REASON Inaccurate test results (false positive or false negative) due to label error. VOLUME OF PRODUCT IN COMMERCE a) 655 kits (IgM); b) 290 kits (IgG). DISTRIBUTION Italy and Belgium. _____________________________ PRODUCT Hand Innovations, Inc. brand of Distal Volar Radius Locking Plate System, Catalog Number is DVR-ST, the common name for the device is the Distal Volar Radius Locking Plate with pegs and screws. Recall # B-0143-3. CODE All lot numbers of the device are involved. RECALLING FIRM/MANUFACTURER Hand Innovations, Inc. Miami, FL, by letter dated August 23, 2002. Firm initiated recall is ongoing. REASON Instructions for use contain an incorrect sterilization procedure. VOLUME OF PRODUCT IN COMMERCE 211. DISTRIBUTION Nationwide and Switzerland, Venezeula, Brazil, Argentina and Mexico. _________________________ PRODUCT Synchron LX 20, Part # 466101; Synchron LX 20 Pro, Part # 466200. Recall # Z-0150-3. CODE All units with software version 2.1 are affected. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter in February 2002. Firm initiated recall is ongoing. REASON Low results on the cartridge chemistry assays, syringe valve seat issue. VOLUME OF PRODUCT IN COMMERCE 793. DISTRIBUTION Nationwide and Canada. _____________________________ PRODUCT a) Exactech brand Optetrak CR Tibial Insert( catalog no. 200-22-09). Recall # Z-0154-3; b) Optetrak PS Tibial (catalog # 204-22-09) inserts. Recall # Z-0155-3. These are used as implants during a knee replacement surgery. CODE a) Serial numbers 0388389 through 0388412; b) Serial numbers 0388600 through 0388623. RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL, by "Important Product Recall Notice" on October 2, 2002. Firm initiated recall is ongoing. REASON The PS tibial insert was labeled as a CR tibial insert. VOLUME OF PRODUCT IN COMMERCE 48. DISTRIBUTION Nationwide, Spain and Luxembourg. _____________________________ PRODUCT Benz Research and Development brand Extreme H20 Contact Lens, diopter - 3.25, Base curve MED, Diameter 14.20. Recall # Z-0156-3. CODE Lot number 8597006813. RECALLING FIRM/MANUFACTURER Benz Research and Development Corp., Sarasota, FL, by letters on or about July 8, 2002. Firm initiated recall is complete. REASON Lenses may be labeled with an incorrect diopter power. VOLUME OF PRODUCT IN COMMERCE 416/6 lens packs. DISTRIBUTION FL and the United Kingdom, France, Switzerland and Germany. RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II _____________________________ PRODUCT Hartz Advanced Care Brand Flea Control Capsules (s)-Methoprene with 8 capsules per package and 154 milligram per capsule for dogs and puppies 9 weeks of age or older weighing 11 to 15 lbs. Recall # V-005-3. CODE Product Code: 32700-96718 Lot No.: 616601, Exp. Date June 14, 2004. RECALLING FIRM/MANUFACTURER Recalling Firm: The Hartz Mountain Corp., Secaucus, NJ, by telephone on July 15, 2002. Manufacturer: The Hartz Mountain Corp., Bloomfield, NJ. Firm initiated recall is ongoing. REASON Labeling and insert contained wrong body weight information. VOLUME OF PRODUCT IN COMMERCE 18105 units. DISTRIBUTION Nationwide.END OF ENFORCEMENT REPORT FOR NOVEMBER 6, 2002 ####
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