99-27 July 7, 1999RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Fresh Romaine Lettuce imported from Israel, packed in plastic bags weighing approximately 350 grams. Recall #F-493-9. CODE None MANUFACTURER Alei Katif - Insect Free Vegetables, Gush Katif, Israel (grower). RECALLED BY Agrexco (USA), Ltd., Jamaica, New York, by telephone on April 19, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 20 cartons (10 units per carton) were distributed; firm estimates none remains on the market. REASON Product was contaminated with salmonella. ________ PRODUCT Mrs. Carberry's Gourmet Cheesecakes: a) Snickers Cheesecake; b) Peanut Butter Cheesecake. Recall #F-494/495-9. CODE All production codes. MANUFACTURER Carberry's Homemade Ice Cream, Inc., Merrit Island, Florida. RECALLED BY Manufacturer, by visit April 8 thru 14, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY Less than 38 cakes were distributed REASON Products contain undeclared peanuts and FD&C Yellow No. 5. ________ PRODUCT Stop & Shop Supermarket Company brand Lactose Free Cakes: a) 1/4 Sheet Lactose Free Chocolate Cake b) 1/4 Sheet Lactose Free Yellow Cake c) 8" Lactose Free Single Layer Yellow d) 8" Lactose Free Single Layer Chocolate e) 8" Lactose Free Sunday Cake/Choc. Cake f) 8" Lactose Free Boston Creme Cake g) 8" Lactose Free Chocolate Crumb Cake h) 8" Lactose Free Yellow Cake i) 8" Lactose Free Chocolate Cake. Recall #F-500/508-9. CODE All cakes sold in Stop & Shop Supermarket in-store bakeries prior to May 15, 1999. MANUFACTURER Maplehurst, Inc., Carrollton, Georgia. RECALLED BY Stop & Shop Supermarket Company, Boston, Massachusetts, by telephone on May 15, 1999, by press release on May 15 & 17, 1999, and by E-mail. Firm-initiated recall complete. DISTRIBUTION Connecticut, Massachusetts, New York, Rhode Island. QUANTITY 416 single layer cakes; 255 double layer cakes, and 328 1/4 sheet cakes were distributed. REASON The cakes contained undeclared eggs.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Cheese products packaged in plastic bags stored in 30 pound cardboard boxes: a) Pauli Shred Blend #5 b) Blended Shredded Cheese #5 (Milking Stool) c) Blended Shredded Cheese #5 (Valley) d) Blended Diced Cheese #5 e) Seal Brand f) Blended Shredded Cheese (Round Table Pizza) Recall #F-487/492-9. CODE Lot #209098-2. Product Codes: 001-5116-376, 001-5116-000, 001- 5116-938, 001-5085-938, 001-5110-838, 750-5046-625. MANUFACTURER Beatrice Cheese, Inc., Gustine, California. RECALLED BY Beatrice Cheese, Inc., Waukesha, Wisconsin, by letter faxed May 6, 1999. Firm-initiated recall ongoing. DISTRIBUTION California, Montana, Oregon, Texas, Idaho. QUANTITY 1,332 cases (39,960 pounds) were distributed. REASON Products may contain pieces of hard plastic. ________ PRODUCT Mrs. Carberry's Gourmet Cheesecakes: a) Hawaiian Pineapple Cheesecake b) Turtle Cheesecake c) Praline Pecan Cheesecake d) Almond Amaretto Cheesecake. Recall #F-496/499-9. CODE All production codes. MANUFACTURER Carberry's Homemade Ice Cream, Inc., Merrit Island, Florida. RECALLED BY Manufacturer, by visit April 8 thru 14, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY Less than 38 cakes were distributed. REASON a) Hawaiian Pineapple Cheesecake contains undeclared FD&C Yellow # 5 b&c) Products contain undeclared pecans and FD&C Yellow # 5. However, in this situation the pecan pieces are on top of the cheesecake where they can be easily seen by the consumer. d) Almond Amaretto Cheesecake contains undeclared almonds.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Levothroid (levothyroxine sodium tablets USP), 50 mcg, packed in 100 tablet bottles, Rx indicated as replacement therapy for diminished thyroid function resulting in hypothyroidism. NDC #00456-0321-01. Recall #D-277-9. CODE Lot #10436. MANUFACTURER Forest Pharmaceuticals, St. Louis, Missouri. RECALLED BY AmeriSource Health Services Corporation, doing business as American Health Packaging, Columbus, Ohio, by letter mailed on April 14, 1999. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Minnesota, Kentucky, Indiana, Florida, New Jersey, Alabama, Maine, Virginia, Georgia, Oregon, Connecticut California, North Carolina. QUANTITY 500 bottles were distributed. REASON Subpotency (stability).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Amicar Syrup 25% (Aminocaproic Acid), each teaspoon (5mL) contains 1.25 g Aminocaproic Acid, in 16 fluid ounce bottles, Rx useful in enhancing hemostasis when fibrinolysis contributes to bleeding. NDC # 58406-611-90. Recall #D-261-9. CODE Lot numbers: 452-657 EXP 1/2001, 452-658 EXP 1/2001, 452-659 EXP 1/2001, 452-660 EXP 2/2001. MANUFACTURER Lederle Laboratories, Pearl River, New York. RECALLED BY Immunex Corporation, Seattle, Washington, by letter during the week of May 17, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,888 bottles of lot 452-657 2,871 bottles of lot 452-658 1,514 bottles of lot 452-659 7 bottles of lot 452-660 were distributed. REASON USP antimicrobial effectiveness test failure (stability). ________ PRODUCT Vivactil 5 mg Tablets (Protiptyline HCl), in bottles of 100, Rx indicated for the treatment of symptoms of mental depression, particularly for withdrawn and anergic patients. NDC #0006-0026- 68. Recall #D-279-9. CODE LOT NOS. A7302 EXP 7/99, B6484 EXP 7/99, B5808 EXP 1/00, B8983 EXP 1/00, B8983SA EXP 1/00, D5744 EXP 1/01, D5039 EXP 4/01, and E6209 EXP 10/01. MANUFACTURER Merck & Company, Inc., West Point, Pennsylvania. RECALLED BY Manufacturer, by letter on May 17, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Firm estimated that 1,000 units remained at wholesale level at time of recall initiation. REASON Subpotency (stability).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Platelets. Recall #B-900-9. CODE Unit #32KH80110. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by telephone on October 27, 1998, and by letter dated November 18, 1998. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product was mislabeled as CMV antibody negative. ________ PRODUCT Platelets. Recall #B-904-9. CODE Unit #0596151. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by letter by letter dated August 11, 1998. Firm- initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the human immunodeficiency virus, but was collected from a donor who previously tested repeatedly reactive for anti-HIV. ________ PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets. Recall #B-925/926-9. CODE Unit #03GW12918. MANUFACTURER American Red Cross, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated December 28, 1998. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had traveled to an area designated as endemic for malaria.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells, Washed. Recall #B-895-9. CODE Unit numbers: 04F47153 and 04J93376. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated February 8, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Red Blood Cells. Recall #B-897-9. CODE Unit #04FV4555. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated March 6, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product was returned due to clotted segments. ________ PRODUCT Allergenic Extract - Pollen Mixes, in 5, 10, 30, and 50 mL vials. Recall #B-916-9 CODE GP03406-1B-1CTI GP03431-1-1CTI GP03431-2B-1CTI GP03431-3B-1CTI PO3441-1-1CTI PO3302-3-1CTI GP03339-2B-1CTI GP03339-1B-1CTI GPO3340-1B-1CTI GP03341-2B-1CTI GP03341-3B-1CTI GP03334-1B-1CTI GP03334-2B-1CTI GP03334-3B-1CTI GP03334-4B-1CTI GP03279-2B-1CTI GP03279-4B-1CTI GP03309-2B-1CTI GP03309-5-1CTI GP03309-6-1CTI GP03309-1B-1CTI GP03310-2B-1CTI GP03310-1B-1CTI GP03311-4-1CTI GP03311-1-1CTI GP03312-2B-1CTI GP03312-3B-1CTI GP03312-4B-1CTI GP03312-5B-1CTI GP03312-6B-1CTI GP03312-1B-1CTI GP03313-2-1CTI GP03425-2-1CTI GP03292-1B-1CTI GP03292-2B-1CTI GP03292-3B-1CTI GP03292-4B-1CTI GP03292-5B-1CTI GP03454-1B-1CTI GP03452-1B-1CTI GP03439-1-1CTI GP03346-1B-1CTI GP03346-2B-1CTI GP03322-1B-1CTI GP03322-2B-1CTI P03462-1-1CTI GP03453-1B-1CTI P03405-1-1CTI GP03445-1-1CTI GP03443-1B-1CTI GP03327-2B-1CTI GP03399-1B-1CTI GP03399-2B-1CTI GP03467-1B-1CTI GP03351-1B-1CTI. MANUFACTURER Greer Laboratories, Inc., Lenoir, North Carolina. RECALLED BY Manufacturer, by telephone on April 6, 1999. Firm-initiated recall complete. DISTRIBUTION California, Colorado, Indiana, Massachusetts, Minnesota, Mississippi, Nevada, New Hampshire, North Carolina, Oregon, South Carolina, Tennessee, Texas. QUANTITY 282 vials were distributed. REASON Allergenic extracts were labeled with an extended expiration date. ________ PRODUCT Platelets. Recall #B-920-9. CODE Unit #03FV52207. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on November 3, 1998. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood that may have had an extended collection time. ________ PRODUCT Platelets, Pheresis. Recall #B-921-9. CODE Unit numbers: 03LQ14033, 03LQ14034, 03LQ14035, 03LQ14037, 03LQ14038, 03LQ14039. MANUFACTURER American Red Cross Blood Services, Columbus, Georgia. RECALLED BY American Red Cross Blood Services, Atlanta, Georgia, by telephone on December 9, 1998. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 6 units were distributed. REASON Blood products were stored at unacceptable temperatures.RECALLS AND FEILD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT IMED Gemini PC-2, 220 Volt Volumetric Infusion Pump/Controller with a titration feature, used to provide automatic infusion of intravascular drugs, fluids, blood and blood components in a hospital environment. Recall #Z-984-9. CODE All serial numbers. MANUFACTURER Alaris Medical Systems, Inc., San Diego, California. RECALLED BY Manufacturer, by letter on April 27, 1999. Firm-initiated recall ongoing. DISTRIBUTION International. QUANTITY 1,410 units were distributed. REASON The device is subject to lockup, resulting in an interruption of fluid delivery caused by an incorrect installation of a Watchdog FET. ________ PRODUCT Ethox brand Weighted Feeding Tube, "Easy Glide", Catalog #9210, Nasogastric/nasointestinal feeding tube with stylet, sterile, disposable. Recall #Z-1008-9. CODE Lot #1712010. MANUFACTURER Ethox Corporation, Buffalo, New York. RECALLED BY Manufacturer, by telephone on March 30, 1999. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Illinois, New Jersey, Washington state, North Carolina, New York, Louisiana, Arizona, California, Puerto Rico, international. QUANTITY 1,660 units were distributed; firm estimated that 622 units remained on market at time of recall initiation. REASON The tungsten weighted tip may separate from the tube during use. ________ PRODUCT 40 cm H20 Pop-off Elbow, (sold separetely and component of Assist Circuit and Resuscitators): a) Stand alone 40cm H20 Pop-off elbow, Product No. BLD-1024; b) BLD Pulmonary Assist Circuit (PAC) containing the 40cm H20 Pop-off elbow, Product No. BLD-83124-2; c) PULMANEX Pulmonary Manual Resuscitators, containing the 40cm H20 Pop-off elbow, Product Nos. BLD-9140, BLD-9142, BLD-9146, BLD-9147, BLD-9187, BLD-9192, BLD-9198, BLD-9244, BLD-9245, BLD-9246, BLD-9249, BLD-9257, BLD-9262, BLD-9291, BLD-9294, BLD-9348, BLD-9390, BLD- 9392, BLD-9394, BLD-9395, BLD-9396, BLD-9397, BLD-9398, BLD-9410. Recall #Z-1028/1030-9. CODE a) Lot Nos. 908083, 909018, 914066; b) Lot Nos.847042, 849005, 907093, 911105, 913060, 915007, 916087, 917108, 919070; c) Lot Numbers between 846000 and 919000. MANUFACTURER BLD Medical Products, Dallas, Texas. RECALLED BY Manufacturer, by letter faxed on May 28 and 29, 1999, and June 1, 1999. Firm-initiated recall ongoing. DISTRIBUTUION Nationwide. QUANTITY 53 elbows; 1,000 PACS and 7,973 resuscitators were distributed. REASON The Pop-off elbow, used to limit valve to maximum pressure, may contain excess plastic material (flash) that could break off and migrate into the patient airway during treatment. ________ PRODUCT Amplicor Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Amplification Kit, Catalog No. 83319/07 59902 (Art. 07 59902), sold as an export only product. Recall #Z-1031-9. CODE Lot No. 19118, EXP 2/99. MANUFACTURER Roche Molecular Systems, Inc., Somerville, New Jersey. RECALLED BY Manufacturer, by electronic mail and telephone on June 19, 1998, by letter on June 18, 1998. Firm-initiated recall complete. DISTRIBUTION Ohio, Michigan, New Jersey, international. QUANTITY 2,116 units were distributed. REASON The CT (+) Control and the CT Internal Control may give low absorbance readings which may give false negative results. ________ PRODUCT Synthes Elastic Intramedullary Nail (Ein) System, Part # 475.935S. Recall #Z-1032-9. CODE Lot S3AS978 MANUFACTURER Synthes (USA), Monument, Colorado. RECALLED BY Synthes USA, Paoli, Pennsylvania, by letter on July 24, 1998. Firm-initiated recall complete. DISTRIBUTION Arkansas, California, Massachusetts, Missouri, Pennsylvania. QUANTITY 19 units. REASON Product was packaged with insert GP0735 which is an insert for One Step Lag Screw. The product should have been packaged with insert GP0935. ________ PRODUCT Laminectomy Punch 40 Degree up-biting, Part #U44-255-30. Recall #Z-1036-9. CODE Lot A7HA13. MANUFACTURER Synthes (USA), Monument, Colorado. RECALLED BY Synthes USA, Paoli, Pennsylvania, by letter on November 6, 1998. Firm-initiated recall complete. DISTRIBUTION Colorado and Missouri. QUANTITY 2 units. REASON Mislabeled - Label indicates punch has a 3 mm bite. The punch in the package (U44-255-20) has a 2 mm bite. ________ PRODUCT Boehringer Mannheim/Hitachi 917 Disk System, a clinical chemistry analyzer system. Recall #Z-1040-9. CODE All versions of the disk system software with an updated barcode reader. This includes the system with Serial No. 9715-05 and all Serial Numbers greater than 9805-10. MANUFACTURER Hitachi Ltd., Instrument Division, Ibari-ken, Japan. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated June 8, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Arizona, California, Connecticut, Delaware, Illinois, Indiana, Iowa, Maryland, Massachusetts, Michigan, New Jersey, Ohio, Pennsylvania, Rhode Island, South Carolina, Washington, West Virginia, Wisconsin, Canada. QUANTITY 32 analyzers were distributed in North America. REASON The barcode reader can read the wrong sample barcode, mismatch the test results, and report them under the wrong sample. ________ PRODUCT CryoValve Allograft (Heart Valve), Model PV00. Recall #Z-1042-9. CODE Serial #6337449, Donor #34109. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter sent on March 19, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit. REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT CryoValve Allograft (Heart Valve), Model PV00. Recall #Z-1043-9. CODE Serial #6185118, Donor #29400. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter sent on March 3, 1999. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit. REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT CryoValve Allograft (Heart Valve), Model PV00. Recall #Z-1044-9. CODE Serial #6330061, Donor #33894. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter sent on February 17, 1999. Firm- initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit. REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT CryoValve Allograft (Heart Valve), Model PV00. Recall #Z-1045-9. CODE Serial #6336493, Donor #34085. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter sent on February 5, 1999. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit. REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT CryoValve Allograft (Heart Valve), Model PV00. Recall #Z-1046-9. CODE Serial #6431348. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter sent on May 18, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit. REASON During a recent review of donor 36936 records, discodant HbcAb results were discovered in the donorís serological testing profile. Current Federal regulations for human tissues mandate that any discordant serological testing results for viral markers be reported as "repeatedly reactive". This donorís serological test for HbcAb was incorrectly report as "nonreactive".RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT 4.5 mm Shaft Screw - 30 mm, Part #214.230. Recall #Z-1033-9. CODE Lot #A3LV413 MANUFACTURER Synthes (USA), Monument, Colorado. RECALLED BY Synthes USA, Paoli, Pennsylvania, by letter on September 1, 1998. Firm-initiated recall complete. DISTRIBUTION California and Oklahoma. QUANTITY 2 units. REASON Seven screws in the lot were mislabeled with a label from part number 209.870 lot #A3LR166 (7.3 mm Cannulated Screw - 70 mm). ________ PRODUCT Flexible Shaft Connector for use with Jacobs Chuck, Part # 351.16J. Recall #Z-1034-9. CODE Lot #3150851. MANUFACTURER Synthes (USA), Monument, Colorado. RECALLED BY Synthes USA, Paoli, Pennsylvania, by letter on October 1, 1998. Firm-initiated recall complete. DISTRIBUTION Arizona, California, Colorado, North Carolina. QUANTITY 5 units. REASON Flexible shaft connector for hand reaming (351.16) was packaged and labeled as a Flexible Shaft Connector for use with Jacobs Chuck (351.16J). The instructions to convert the part were not complete. ________ PRODUCT TI-6AL-7NB URTN, Part number 476.36S, a tibial nail. Recall #Z-1035-9. CODE Lot #A3LO480. MANUFACTURER Synthes (USA), Monument, Colorado. RECALLED BY Synthes USA, Paoli, Pennsylvania, by letter on October 16, 1998. Firm-initiated recall complete. DISTRIBUTION Alabama, Hawaii, Kansas, Missouri, New Mexico, New York, Oklahoma, Virginia, Washington state. QUANTITY 12 units. REASON Mislabeled - The outside package indicates the product is a Ti Solid Tibial Nail 10 mm x 360 mm (476.36S). The contents of the inner package are a Ti Cannulated Tibial Nail 13 mm x 420 mm (458.342S) of Lot #A3LH315. ________ PRODUCT Synthes Anatomical Locking Plate System, Part #292.699.111. Recall #Z-1037-9. CODE Lot 3153892. MANUFACTURER Synthes (USA), Monument, Colorado. RECALLED BY Synthes USA, Paoli, Pennsylvania, by letter ON March 4, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama, Colorado, Missouri, Mississippi, New York, Pennsylvania. QUANTITY 210 units. REASON The device is 275 mm long instead of 280 mm.END OF ENFORCEMENT REPORT FOR JULY 7, 1999.