August 6, 1997 97-32 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Sea Legs brand Whole Leg Style Imitation King Crabmeat, in 5 pound clear plastic bags. Recall. #F-568-7. CODE 2 7134. MANUFACTURER Sugiyo USA, Inc., Anacortes, Washington. RECALLED BY Manufacturer, by letter on June 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION Washington state. QUANTITY 334 30-pound cases were distributed. REASON Product is contaminated with Listeria monocytogenes. _______________ PRODUCT Dips, salads, grape leaves and salsa under the Cedar's label: 1. Original Hommus Tahini 2. Mediterranean Spice Hommus Tahini 3. No Salt Added Hommus Tahini 4. Baba Ghannouj 5. Roasted Baba Ghannouj 6. Garlic & Chive Hommus Tahini 7. Roasted Red Pepper Hommus Tahini 8. Roasted Almond Hommus Tahini 9. Pimento & Olive Hommus Tahini 10. Sundried Tomato & Basil Hommus Tahini 11. Sauteed Onions & Peppers Hommus Tahini 12. Vegetable Hommus Tahini 13. Garlic Lovers Hommus Tahini 14. Beantown Sport Dip 15. Garden Lentil Salad 16. Taboule Salad 17. Grape Leaves Stuffed with White Rice 18. Boston Vegetable Salsa Dips under the Mr. Hommus label: 19. Original Hommus 20. Salsa Hommus 21. Garlic Hommus 22. Dill Hommus 23. Scallion Hommus 24. Vegetable Hommus 25. Roasted Garlic & Chive Hommus 26. Roasted Red Pepper Hommus 27. 40 (or Magic) Spice Hommus 28. Sun-dried Tomato & Basil Hommus 29. Sport Dip The following dips under the Vita Heavenly Hommus! label: 30. Original Hommus 31. Dill Hommus 32. Extra Garlic Hommus 33. Vegetable Hommus 34. Roasted Red Pepper Hommus 35. Lemon Dill Hommus 36. Spice Hommus 37. HOT!!! Red Pepper Hommus 38. Tomato & Basil Hommus 39. Bagel with Chives Hommus 40. Bagel Hommus The following dips and salads under the Sidon label (distributed in Canada only): 41. Original Hommus Tahini 42. Piment & Olive (Pimento & Olive) Hommus Tahini 43. Pour Les Amants D'Lail (Garlic Lovers) Hommus Tahini 44. Vegetable Hommus Tahini 45. Baba Ghannouj 46. Salad de Lentilles Jardiniere (Garden Lentil Salad) 47. Salade Taboule. Recall #F-569/615-7. CODE All lots. MANUFACTURER Cedars Mediterranean Foods, Inc., Plaistow, New Hampshire. -2-RECALLED BY Manufacturer, by telephone beginning on June 12, 1997, followed by fax. Firm-initiated recall ongoing. See Also FDA press release dated June 12, 1997. DISTRIBUTION Hawaii, New Hampshire, Vermont, Connecticut, Massachusetts, Maryland, Maine, New York, New Jersey, Pennsylvania, Rhode Island, Illinois, North Carolina, South Carolina, Georgia, Virginia, Michigan, Minnesota, Ohio, Canada. QUANTITY 1,166,857 units produced between April 1997 to June 12, 1997 (including 8 ounce, 16 ounce, 5 pound). REASON The products may be contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall B-1079/1082-7. CODE Unit numbers: KH71577, KH72926, KH74741; b) KH71577; c) KH71577; (d) KH72926, KH74741. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, telephone and fax on April 25, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia, Illinois, California, Switzerland. QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 2 units were distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1098/1099-7. CODE Unit #36FK11300. MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by letter dated April 11, 1997, and by fax on April 4, 1997. Firm-initiated recall complete. DISTRIBUTION South Carolina and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose spouse has hepatitis C. _______________ PRODUCT Fresh Frozen Plasma, Pheresis. Recall #B-1100-7. CODE Unit #4020498. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. -3-RECALLED BY Manufacturer, by telephone on January 17, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with an elevated body temperature. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-1104-7. CODE Unit #03GT25232. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on May 16, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of Red Blood Cells that was reported as clotted. _______________ PRODUCT a) Platelets; b) Fresh Frozen Plasma. Recall #B-1105/1106-7. CODE Unit #03GP11980. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on June 4, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit of each component was distributed. REASON Blood products were prepared from a unit of Whole Blood designated as a "difficult collection". _______________ PRODUCT Platelets. Recall #B-1107-7. CODE Unit #03FJ41109. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on June 3, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood designated as a "difficult collection". _______________ PRODUCT Platelets. Recall #B-1108-7. CODE Unit #28GM03018. MANUFACTURER American Red Cross Blood Services, Savannah, Georgia. RECALLED BY Manufacturer, by telephone on or about March 3, 1997. Firm-initiated recall complete. -4-DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood designated as a "difficult collection". _______________ PRODUCT Platelet Pheresis, Split unit. Recall #B-1109-7. CODE Unit #21P67362. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letter dated May 20, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Platelet Pheresis, Irradiated. Recall #B-1110-7. CODE Unit #21P67582. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letter dated May 20, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1112/1115-7. CODE Unit numbers: a) 4002374, 7108543, 7407945, 7133679, 7332989, 4008031, 1800905, 1820061, 7716673; b) 7108543, 7407945, 4008031, 7716673; c) 7716673; d) 7108543, 7407945, 7133679, 7332989, 4008031, 1800905, 1820061. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by letters dated June 5 and 25, 1997, July 9, 1997 or July 15, 1997. Firm-initiated recall ongoing. DISTRIBUTION Illinois, California, Arizona, District of Columbia. QUANTITY a) 9 units; b) 4 units; c) 1 unit; d) 7 units were distributed. -5-REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative. _______________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, for further manufacture; c) Platelets; d) Platelets, for further manufacture; e) Fresh Frozen Plasma; f) Cryoprecipitated AHF; g) Recovered Plasma. Recall #B-1116/1122-7. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 594-1191 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letters dated January 30, 1996, or July 5, 1996, and on February 1, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio, Michigan, Kentucky, Georgia, West Virginia, California, New York, Illinois, Switzerland. QUANTITY a) 53 units; b) 2 units; c) 20 units; d) 7 units; e) 9 units; f) 10 units; g) 47 units were distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), and were subjected to additional retesting. _______________ PRODUCT a) Red Blood Cells; b) Red Blood Cells (Irradiated); c) Platelets; d) Platelets (Irradiated). Recall #B-1130/1133-7. CODE Unit numbers: a) 1008883; b) 3000751; c) 1008883; d) 3000751. MANUFACTURER Community Blood Center, Dayton, Ohio. RECALLED BY Manufacturer, by letter on February 18, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Platelet Pheresis, Leukodepleted. Recall #B-1066-7. CODE Unit #40P53940. -6-MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on May 27, 1997, and by letter on June 9, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was distributed without obliteration of U.S. license. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1070/1072-7. CODE Unit numbers: a) 5047904; b) 5047904 and 5047905; c) 5047904 and 5047905. MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on May 27, 1997, followed by letters dated May 28, 1997 or June 11, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio and Kentucky. QUANTITY 1) 1 unit; b) 2 units; c) 2 units were distributed. REASON Blood products were incorrectly tested for the hepatitis B surface antigen (HBsAg), and a subsequent donation which tested negative for HBsAg. _______________ PRODUCT Red Blood Cells. Recall #B-1073-7. CODE Unit numbers: 30167-6907, 30167-6925, 30167-6939, 30167-6943. MANUFACTURER United Blood Services, Bismark, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 20, 1996. Firm-initiated recall complete. DISTRIBUTION South Dakota. QUANTITY 4 units were distributed. REASON Unlicensed blood products were distributed labeled with the firm's license number. _______________ PRODUCT Red Blood Cells. Recall #B-1076-7. CODE Unit #9503178. MANUFACTURER LifeShare Blood Centers, Beaumont, Texas. RECALLED BY LifeShare Blood Centers, Shreveport, Louisiana, by telephone on February 13, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receipt of post donation cold symptoms. -7-_______________ PRODUCT Red Blood Cells. Recall #B-1078-7. CODE Unit #30168-7277. MANUFACTURER United Blood Services, Bismarck, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 23, 1996. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 1 unit was distributed. REASON Blood product remained at room temperature for an unacceptable length of time. _______________ PRODUCT Buffy Coat. Recall #B-1083-7. CODE Unit #KH74741. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on April 25, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. _______________ PRODUCT a) Platelets; b) Fresh Frozen Plasma. Recall #B-1093/1094-7. CODE Unit #KQ21662. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on or about December 22, 1995. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the antibiotic Cipro. _______________ PRODUCT Source Plasma. Recall #B-1096-7. CODE Unit #G-56799-081. MANUFACTURER Alpha Therapeutic Corporation, Charlotte, North Carolina. RECALLED BY Alpha Therapeutic Corporation, Los Angeles, California, by letter on September 26, 1996. Firm-initiated recall complete. DISTRIBUTION Spain. QUANTITY 1 unit was distributed. REASON Blood product tested positive for syphilis by RPR. _______________ PRODUCT Red Blood Cells. Recall #B-1097-7. CODE Unit #18Q91042. -8-MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated March 7, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose screening was inadequately performed. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-1101/1103-7. CODE Unit #KE53396. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated December 9, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia and Utah. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug, Mellaril. _______________ PRODUCT Red Blood Cells. Recall #B-1111-7. CODE Unit #21GJ79343. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on May 8, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-1128-7. CODE Unit numbers: 16LN06282, 16LR08707, 16LY18116. MANUFACTURER American National Red Cross, Columbus, Ohio. RECALLED BY Manufacturer, by letter on December 10, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and American Samoa. QUANTITY 3 units were distributed. REASON Unit of pooled platelets implicated in a post transfusion reaction were found to be contaminated with Proprionibacterium acnes. _______________ PRODUCT Red Blood Cells Leukodepleted. Recall #B-1129-7. CODE Unit #16LS10360. MANUFACTURER American National Red Cross, Columbus, Ohio. RECALLED BY Manufacturer, by letter on October 10, 1996. Firm-initiated recall complete. -9-DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Red Blood Cells were leukodepleted by filtration greater than five days past the time of collection. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Reusable POLYCARBONATE DOMES without Diaphragm, Catalog No. TA1010"D", used to help measure physiological pressure by serving as a reservoir for sterile liquid and converts the incoming pressure into an electrical output for the monitor. Recall #Z-690-7. CODE Lot Nos. SD1206, SD1207, SD1223, SD1286, SD1302, SD1342. MANUFACTURER Ohmeda (Singapore), Singapore. RECALLED BY Ohmeda Medical Devices Division, Inc., Murray Hill, New Jersey, by letter dated January 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION Florida, Alabama, Washington state, New Jersey, Illinois, California. QUANTITY 2,238 pieces were distributed. REASON The lots incorrectly contain the suffix "D" which indicates a single use, sterile device, when in fact they are reusable non-sterile devices. _______________ PRODUCT ECOSYSTEM Endoscopic Ligation Cartridges, used as a part of the Weck Hemoclip Ecosystem Ligation System: a) Catalog No. 140145; b) Catalog No. 140245; c) Catalog No. 140601; d) Catalog No. 140603; e) Catalog No. 140604. Recall #Z-692/696-7. CODE All Lots. MANUFACTURER Pilling Weck, Inc., Research Triangle Park, North Carolina. RECALLED BY Manufacturer, by letter on May 27, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 48,914 products were distributed. REASON Products are subject to improper clip closure. _______________ PRODUCT InstaTrak Systems containing an Electromagnetic Tracking Device, used for the acute and chronic sinusitis endoscopic, dacryocystorhinostomy, optic nerve and orbital decompression, the removal of polyps, the -10- biopsy and removal of tumors, and the repair of CSF leaks, pituitary disorder, and encephalocele: a) InstaTrak System, Catalog No. IT-100ENT, an Image Guided Surgery System that employs a computer, software and electromagnetic tracking device that is used for endoscopic sinus surgery; b) ConneCTstat Workstation, Catalog No. CS-100, an independent workstation used to archive CT images onto a cartridge which maybe used on the InstaTrak System during surgery. It does not have a position sensing and tracking capabilities. Recall #Z-751/752-7. CODE Serial Nos. a) IT-10012, IT10013, IT10015, IT10016, IT10020, IT10021, IT10022, IT10024, IT10027, IT10029; b) CS101, CS102. MANUFACTURER Visualization Technology, Inc., Woburn, Massachusetts. RECALLED BY Manufacturer, by letter June 13, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York, Tennessee, Minnesota, Ohio, District of Columbia, Massachusetts, Illinois, Pennsylvania. QUANTITY (a) 10 units; b) 2 units were distributed. REASON The firm was found to be not in conformance with the Good Manufacturing Practice (GMP) for Medical Devices Regulation, in that it failed to provide adequate documentation the Electromagnetic Tracking Device (P/N 1000045-001) met the firm's specifications. _______________ PRODUCT QuickStripe Chlamydia Ag, Catalog No. 1185/0185, a rapid, visual assay for the detection of Chlamydia trachomatis antigen in endocervical, urethral, or male urine specimens. Recall #Z-753-7. CODE Kit Lot No. 0005-1. MANUFACTURER Chembio Diagnostics Systems, Inc., Medford, New York. RECALLED BY Diatech Diagnostics, Inc., Boston, Massachusetts (distributor), by letters on May 8, 1997, and June 3, 1997. Firm-initiated recall ongoing. DISTRIBUTION Russia, Egypt, Miami (Trinidad). QUANTITY 302 kits (20 tests per kit) were distributed. REASON The cassette has a shortened "lip" for holding the test membrane in place, making it difficult to read the results. -11-_______________ PRODUCT Revolution Manual Wheelchair. Recall #Z-768-7. CODE Various serial numbers. MANUFACTURER Quickie Designs, Inc., Fresno, California. RECALLED BY Manufacturer, by letter on June 12, 1997. Firm-initiated recall complete DISTRIBUTION Nationwide and international. QUANTITY 2,749 units were distributed. REASON The Caster Hinge and Bolt may potentially detach causing the wheelchair to collapse and the user to fall and be injured. _______________ PRODUCT Lead Aprons, Vests, Wraps, Thyroid Collars and Gonad Shields, radiation protective devices: a) Aprons; b) Apronettes; c) Mini Aprons; d) Apron with Thyroid Collar; e) Wraps; f) Jackets; g) Vests; h) Skirt; i) Vest and Skirt; j) Thyroid Collars; k) Gonadal Shields. Recall #Z-769/779-7. CODE a) Aprons E-Z-EM, Inc. Catalog Numbers -- Lot Numbers: A241 - Lot 132; A25F - Lot: 274; A25H - Lot: 130, 131; A25K - Lots: 123, 131, 132, 134; A32J - Lots: 104, 186; A32K - Lot: 104; A32M - Lot: 186; A33F - Lot: 113; A33H - Lot: 113; A33K - Lot: 93677; A33M - Lots:113, 284; A33S - Lot: 285; A35F - Lots: 123, 134, 274; A35G - Lots: 113, 134, 276; A35J - Lots: 113, 123; A35K - Lots: 102, 113,130, 132, 133, 134, 144; A35L - Lots: 113, 130; A35M - Lots: 113, 130, 284; A35S - Lots: 113, 130 285; A43H - Lot: 286; A44H - Lot: 112; A44K - Lot: 186; A45K - Lots: 285, 286; A47G - Lots 102, 113, 123, 131, 165; A47H - Lots: 102, 113, 116, 126, 285, 132625; A47K - Lots: 111, 113, 123, 126, 130, 131; A77G - Lot: 134; AF32G - Lot: 104; AF35G - Lots: 102, 104, 113, 116, 123, 126, 236; AF35H - Lots: 104, 113, 116, 131, 230; AF35J - Lots: 108, 111, 116, 123, 133; AF35K - Lots: 113, 116, 123, 130, 131, 132, 133, 134; AF35L - Lots: 102, 108, 116, 133, 276; AF35M - Lots: 111, 116, 133, 134, 284; AF35S - Lots: 116, 130, 133, AF51K - Lots: 198, 285; AF52K - Lots: 274, 277; AF52S - Lot: 277; AF54H - Lot: 134; AF54K - Lots: 130, 131; AF54M - Lots: 133, 134, 269; AF54S - Lot: 269; AF55K - 130, 277, AF55S - Lot: 129, AF73S - Lot: 285, AF75G - Lot: 104, AF75K - Lot: 104, AF77G - Lots: 102, 123, 129, 165, 285, -12- AF77H - Lots: 116, 123, 126, 165, 191, AF77J - Lot: 285, AF77L - Lot: 144, AF83J - Lot: 123, AF85F, Lot: 113, AF85G - Lot: 116, AF85H - Lot: 131; AF85J - Lots: 123, 133; AF85K - Lots: 113, 123, 130, AF85L - Lot: 113; AF85M - Lot: 116; AF85S - Lot: 134; AF85T - Lot: 113; AF95F - Lot: 111, AF95G - Lots: 111, 129, 276; AF95H - Lots: 102, 116, 130; AF95K - Lots: 102, 111, 113, 123, 130, 134, 144, 234, 236; AF95L - Lots: 111, 116, 126, 130, 133, 276; AF95M - Lots: 112, 113, 130 133; AF95S - 116, 130, 133, 134, 135, A900 - Lots: 113, 116, 133, 134, 144. Picker Sentry Lite, Catalog Numbers, Lot Numbers: 253176 - Lots: 113, 116,133, 134, 274; 253177 - Lots: 102, 111, 113, 116, 129, 130, 131, 134, 274; 253178 - Lots: 108, 116, 130, 274; 253179 - Lot: 274; 253180 - Lots: 113, 116, 129, 131, 134; 253181 - Lots: 113, 123, 131, 144; 253369 - Lots: 116, 131, 132, 134, 138, 165, 276, 288; 253370 - lots: 113, 116, 123, 134, 276, 288; 253371 - Lots: 113, 116, 123, 129, 131, 276, 288; 253376 - Lots: 133, 134; 253377 - Lots: 130, 133, 134; 253378 - Lots: 131; 253379 - Lots: 131, 134; 256008 -Lots: 130, 136; 256009 - Lots: 131, 177; 256223 - Lots: 131, 133; 256227 - Lots: 116, 131, 134; 256228 - Lots: 113, 116, 276; 256229 - Lots: 133, 276; 256233 - Lot: 961091; 256236 - Lot: 116; 256237 - Lots: 116, 129, 130, 131, 133, 134; 256238 - Lots: 111, 113, 131, 132, 134, 165; 256239 - Lots: 131, 132, 133; 256253 - Lots: 134, 274, 276; 256254 - Lots: 134, 234; 256255 - lots: 113, 116, 130, 134, 276; 256258 - Lots: 111, 116, 134; 256259 - Lots: 111, 133, 234, 288; 256260 - Lots: 111, 113, 116, 129, 130, 133, 134, 276, 286; 256261 - Lots: 113, 133, 276, 280, 286; 257882 - Lots: 108, 129, 133, 276; 258042 - Lot: 286; 258043 - Lots: 104, 116, 165, 280; 258078 - Lots: 130, 134, 286; 258080 - Lots: 113, 129, 130, 133, 288; 258200 - Lots: 116, 126; 258889 - Lot: 116; 258891 - Lots: 104, 108; 258892 - Lot: 133; 258894 - Lots: 104, 131; 258895 - Lots: 104, 108, 113, 116, 123, 130, 134; 258896 - Lots: 104, 108, 116, 126, 130; 258897 - Lots: 108, 113, 134, 276; 259249 - Lot: 144; 261871 - Lot: 286; 261872 - Lot: 274; 261876 - Lot: 144; 261885 - Lot: 134; 263694 - Lots: 126, 129, 131, 133; -13- 263695 - Lots: 113, 129, 132, 133; 264622 - Lots: 134, 284; 264624 - Lot: 105; 264625 - Lots: 111, 116, 131, 133, 223, 234, 284, 286; 264626 - Lots: 102, 130, 276; 264627 - Lots: 131, 165, 236; 264628 - Lots: 111, 131, 234; 264629 - Lots: 113, 144 264630 - Lots: 129, 130, 134, 165 264631 - Lot: 276; 264632 - Lot: 131 264633 - Lots: 113, 144 264634 - Lots: 105, 113, 116, 129, 276 264635 - Lots: 130, 276 264636 - Lots: 113, 116, 129, 131, 133, 276 264637 - Lots: 129, 133, 134, 274, 276, 286 264638 - Lots: 113, 116, 129, 276 264639 - Lots: 131, 136, 276, 286 264709 - Lot: 136; 265287 - Lots: 113, 133 265288 - Lots: 129, 276; 265289 - Lots: 133, 276; 265492 - Lots: 116, 131, 276 265493 - Lot: 129; 265494 - Lot: 134 265495 - Lots: 136, 138, 190 265496 - Lots: 136, 177l; 265497 - Lots: 136, 138; 265513 - Lots: 104, 105, 108, 116, 126, 130, 131, 134; 136, 190, 223, 234, 276 265579 - Lots: 140, 190; 266191 - Lot: 116 266192 - Lot: 134; 266193 - Lot: 134 266194 - Lot: 131; 266195 - Lot: 104 266197 - Lot: 116, 131, 165 266198 - Lot: 136; 266228 - Lot: 116, 123, 236 266229 - Lot: 113, 134, 62694 266230 - Lot: 131; 266231 - Lots: 104, 126, 137; 266232 - Lots: 108, 116 266233 - Lots: 108, 144 266236 - Lots: 144, 165, 236 266238 - Lot: 104; 266239 - Lot: 234 266240 - Lot: 126; 266241 - Lot: 294 266245 - Lots: 144, 223, 234 266246 - Lot: 126; 266305 - Lot: 105 269682 - Lot: 104; 269683 - Lots: 104, 111, 113, 129, 130, 133, 234, 276 269684 - Lots: 111, 113, 116, 130, 131, 133, 134, 235, 284, 286, 294 269685 - Lots: 104, 111, 113, 129, 130, 234 269686 - Lots: 111, 131, 234, 276 269687 - Lots: 104, 111, 113,116, 130, 131, 234, 276, 284 269688 - Lots: 116, 130, 133, 134, 234, 276 269689 - Lots: 104, 111, 113, 116, 130, 131, 134, 223, 234, 223, 276, 284, 286 269690 - Lots: 136, 190 400802 - Lots: 102 400803 - Lots: 102, 113, 234 -14- 400804 - Lots: 130, 234 400805 - Lots: 286; 264625T - Lot: 144 264626T - Lot: 144; 264628T - Lots: 144, 223 264634T - Lots: 105, 126 264635T - Lots: 105, 126; 264636T - Lot: 126 264637T - Lot: 126, 144; 264638T - Lots: 104, 236; 264639T - Lot: 102 265287T - Lots: 108, 126; 265289T - Lot: 126 265493T - Lot: 126; 265497T - Lots: 190, 191 266195T - Lot: 104; 266197T, Lot: 104, 126 269683T - Lots: 105, 126, 144 269684T - Lots: 102, 108, 126, 144, 236 269685T - Lots: 108, 144, 236, 260 269686T - Lots: 104, 126, 144, 223 269687T - Lots: 126, 144, 223, 236 269688T - Lots: 104, 260 269689T - Lots: 104,108, 126, 223, 260, 276 269690T - Lot: 190; 9EZM79J - Lot: 116 9EZM79K - Lots: 113, 130, 131, 132, 133, 280 9EZM79L - Lots: 116, 134 9EZM79S - Lots: 116, 284; EC94 - Lot: 133 b) Apronettes E-Z-EM Catalog Numbers - Lot Numbers: A15A - Lots: 113, 133, 134 A15B - Lots: 113, 133, 134, 286 A15C - Lots: 123, 130, 134 A15D - Lots: 113, 116, 130, 134, 286 A15E - Lots: 113, 116, 123, 130, 132, 133, 230, 274 c) Mini Aprons Picker Catalog Numbers - Lot Numbers: 258162 - Lots: 113, 116, 129, 131, 132, 133, 134, 288 258163 - Lots: 113, 116,129, 130, 131, 132, 133, 134, 223, 280, 286, 288 258164 - Lots: 113, 116, 123, 129, 130, 131, 132, 133, 223, 277, 286, 288 258165 - Lots: 113, 116, 123, 129, 132, 133, 134, 288; 259356 - Lots: 113, 130 d) Apron with Thyroid Collar Picker Catalog Numbers - Lot Numbers: 253372 - Lot: 130; 253373, Lot: 134 256017 - Lots: 116, 276 256018 - Lots: 113, 116, 130, 133, 286 256019 - Lots: 116, 130, 134, 280, 286 256020 - Lots: 116, 133 256021 - Lots: 116, 131, 133 256022 - Lots: 131,133 265514 - Lots: 165, 177 265515 - Lots: 104, 126, 236 266247 - Lots: 104,126,144, 165, 236 266248 - Lot: 236; 266249 - Lot: 105 -15- e) Wraps E-Z-EM Catalog Numbers - Lot Numbers: AFS7L - Lots: 134, 274, 091594 AFS7M - Lots: 126, 134 AS7L - Lot: 134; AS7M - Lots: 116, 134 Picker Catalog Numbers - Lot Numbers: 256241 - Lot: 129; 256242 - Lot: 131 256243 - Lot: 134; 256246 - Lot: 130 265501 - Lot: 104, 113,127, 130, 134, 165, 223 265503 - Lot: 92877 265504 - Lots: 104, 105, 126, 127, 129, 134, 144, 165, 223, 233, 236, 274 265505 - Lots: 105, 108, 111, 116, 127, 134 265506 - Lots: 129, 144 265510 - Lots: 102, 104, 116, 123, 126, 127, 134, 136, 144, 165, 223, 236 265511 - Lots: 104, 123, 165 265512 - Lots: 144, 236 265517 - Lots: 126, 131 265727 - Lots: 123, 134, 223 265729 - Lots: 116, 123 266203 - Lot: 104 266204 - Lot: 129 266205 - Lots: 108, 116, 234 266206 - Lot: 116 f) Jackets Picker Catalog Numbers - Lot Numbers: 264640 - Lots: 104, 105, 108, 113, 116, 130, 134, 165, 223, 236, 276 264641 - Lot: 111; 264642 - Lot: 289 264643 - Lots: 104, 105, 126, 134, 165, 223, 233, 236 264644 - Lots: 104, 105, 108, 116, 126, 134, 223; 264645 - Lot: 144 264649 - Lots: 104, 111, 116, 126, 127, 133, 136, 144, 223, 236 264650 - Lots: 104,123, 165 264651 - Lots: 123, 144, 236 265498 - Lots: 123, 129, 134, 144,223, 234 265516 - Lots: 108, 126, 144, 165, 236 266199 - Lots: 104, 081095 266200 - Lots: 129, 234 266201 - Lots: 108, 116 266202 - Lot: 165 g) Vests E-Z-EM Catalog Numbers - Lot Numbers: AFV7L - Lot: 134 AFV7M - Lots: 126, 134 AFV7S - Lot: 123; AV7L, Lot: 134 AV7M - Lots: 116, 134 Picker Catalog Numbers - Lot Numbers: 266526 - Lot: 104; 266527 - Lot: 104 -16- 266528 - Lots: 108, 130 266529 - Lots: 108, 111 266530 - Lot: 108; 266532 - Lot: 102 266542 - Lot 108; 266543 - Lot 108 266550 - Lot 130 253369V - Lots: 113, 129, 131, 276 253370V - Lots: 113, 123, 129, 131, 134 253371V - Lots: 129, 131, 133, 134, 276 h) Skirt Picker Catalog Numbers - Lot Numbers: 266535 - Lots: 104, 130 266536 - Lots: 102, 108 266537 - Lot: 108; 266538, Lot: 108 266540 - Lot: 111; 266547, Lot: 108 266549 - Lot: 102; 266551 - Lot: 144 I) Vest and Skirt Picker Catalog Numbers - Lot Numbers: 256247 - Lots: 104, 116, 133, 134 256248 - Lots: 102, 104, 116, 129, 133, 134 256249 - Lots: 102, 108 256251 - Lot: 116 256252 - Lots: 130, 131, 133 257896 - Lots: 104, 108, 144 261953 - Lots: 135, 144 261954 - Lots: 123 j) Thyroid Collars E-Z-M Catalog Numbers - Lot Numbers: A656; 5x25 - Lots: 102, 113, 116, 123, 129, 130, 131, 132, 133, 134, 144, 165, 236, 274, 276, 277, 284, 285, 286, 294, 89993 Picker Catalog Numbers - Lot Numbers: 254179 - Lots: 104, 113, 116,, 123, 129, 130, 131, 132, 133, 134, 140, 246, 274, 276, 284, 286, 288 254180 - Lots: 113, 116, 129, 130, 133, 134, 276, 286 258419 - Lots: 108, 113, 116, 123, 129, 130, 131, 133, 134, 223, 276, 280, 284, 286 264736 - Lot: 280 265544 - Lots: 113, 116, 123, 126, 129, 130, 131, 133, 236, 276, 280, 284 265545 - Lots: 113, 116, 123, 129, 130, 131, 133, 144, 234, 276 265546 - Lots: 113, 116, 125, 129, 131, 239, 269 266207, Lots: 116, 123, 130, 131, 134, 144, 165 k) Gonadal Shields Picker Catalog Numbers, Lot Numbers: 254178 - Lots: 110, 113, 116, 117, 118, 119, 128, 129, 131, 133, 136, 144, 145, 168, 169, 180, 181, 191, 197, 198, 199, 202, 206, 207, -17- 210, 213, 216, 224, 230, 236, 237, 246, 269, 277, 285, 286, 1144, 8293, 8693, 8994, 9213, 9393, 10496, 62094, 62294, 91594, 92093, 92194, 92328, 92329, 92334, 92339, 92387, 92430, 92436, 92437, 92438, 92549, 92663, 92772, 92872, 93221, 933326, 93328, 93343, 93443, 93449, 93450, 93671, 93673, 95449, 101493, 101493, 121693, 921197, 1074205, 1075215, 1076233, 1077258, 1079266, 1081300, 1132967, 9112344, 9211105, 9211106, 9212107, 9212108, 9212109, 11381011, 11381014, 11381020, 11431069, 011094, 92-10-94, 92-11-97, 98-11-97 262004 - Lots: 113, 116, 117, 119, 128, 129, 131, 132, 133, 135, 141, 144, 162, 168, 179, 180, 183, 191, 197, 198, 202, 207, 210, 213, 224, 236, 248, 269, 285, 286, 8994, 9213, 11294, 92194, 92436, 92549, 92664, 92668, 92772, 92872, 92876, 93443, 93892, 1075213, 1076213, 1132971, 1137999, 11381020, 011094. MANUFACTURER E-Z-EM, Inc., Westbury, New York. RECALLED BY Manufacturer, by letters on June 6, 9, 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY E-Z-EM & Picker Int'l labeled Aprons, Vests, and Wraps: a total of 2270 units (domestic & foreign combined) E-Z-EM labeled Thyroid Collars: 560 units Picker International Thyroid collars: 1014 units (930 domestically, 84 foreign) Picker International Gonad Shields: 694 units (681 domestically, 13 foreign). REASON The radiation protection devices contain lead contaminated with small amounts of radioactive substances. _______________ PRODUCT Pilling Weck Manual Endoscopic Hemoclip Applier, Catalog #113511, for use in endoscopic application of Pilling Weck Hemoclips. Recall #Z-795-7. CODE All lot numbers. MANUFACTURER Hauser Medizintechnik, Gosheim, Germany (units date stamped 1/96 - 1/97); Edlo, SA Productos Medicos, Canoas, Brazil (units marked "Brazil"). RECALLED BY Pilling Weck, Inc., (now Weck Closure Systems), Research Triangle Park, North Carolina, by letters on December 20, 1996, and May 7, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide, Mexico, Brazil, Peru, Puerto Rico, Canada, Argentina. -18-QUANTITY 1,034 products were distributed. REASON The luer lock can become loose and/or the rotation knob may experience cracking which could affect the intended function of the applier. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT STA-PTT-LT(5) Catalog No. 00668. The kit provides reagent for the determination of the activated partial thromboplastin time (APPT) which is used as a general coagulation screening test. Recall #Z-743-7. CODE Lot Nos. 951178, 951300, 962051, 962681, 963101, and 963382. MANUFACTURER Diagnostica Stago, Franconville, France. RECALLED BY American Bioproducts Company, Parsippany, New Jersey,, by letter sent on February 24, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY LOT # AMT SHIPPED (BOXES) 951178 740 951300 235 962051 293 962681 96 963101 23 963382 51. REASON Product is contaminated by Penicillium. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I =========== _______________ PRODUCT Purina Sweetina Horse Feed (nonmedicated), in 50 pound bags. Recall #V-037-7. CODE Lot #3525. MANUFACTURER Purina Mills, Inc., Macon, Georgia. RECALLED BY Manufacturer, by telephone on February 10, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia and Alabama. QUANTITY 113 bags were distributed. REASON Feed was likely contaminated with medicated feedlot feed containing monensin and tylosin. MEDICAL DEVICE SAFETY ALERTS: ============================== _______________ PRODUCT Datascope-Cardiac Assist Insertion Kits for use with Datascope Intra-Aortic Balloons and Datascope-Cardiac Assist Introducer Single Pack Kits for use with Datascope Inra-Aortic Balloons. Safety Alert #N-016/027-7. -19-CODE 1. Model No. 0684-00-0187-01, Lot No. UN; 2. Model No. 0684-00-0257, Lot Nos. TZ, UO; 3. Model No. 0684-00-0264, Lot Nos. UF, UC, TW, VE, VF, VW, VZ; 4. Model No. 0784-00-0114, Lot Number None indicated; 5. Model No. 0784-00-0125, Lot Nos. VG, VP; 6. Model No. 0684-00-0251-11, Lot Nos. UE, UD, UJ, UL,VS, VY; 7. Model No. 0784-00-0103-04, Lot No. UA; 8. Model No. 0784-00-0128, Lot Nos. VA, VN; 9. Model No. 0684-00-251-13, Lot Nos. QU, UH, UG, UB, TY, TX, TU, UI, UP, VC, VD, VI; 10. Model No. 0784-00-0129, Lot Nos. VB, VQ; 11. Model No. 0784-00-0103-13, Lot No. UM; 12. Model No. 0684-00-0208, Lot No. UQ. MANUFACTURER Datascope, Cardiac Assist Division, Fairfield, New Jersey. Alerted By Manufacturer, by letters on September 27, 1996, October 2 and 3, 1996. DISTRIBUTION Nationwide and international. QUANTITY 27,856 units were distributed. REASON The inadvertent removal of the hemostasis valve which may lead to the unanticipated blood loss to the patient. Notification also included instructions regarding use of subject device, and how to minimize bleeding if hemostasis valve is removed. END OF ENFORCEMENT REPORT FOR AUGUST 6, 1997. BLANK PAGES MAY FOLLOW. -20- ####End of Enforcement Report for