November 19, 1997 97-47 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Hummus and Baba Ganouch under the following labels: Tribe of Two Sheiks label: 1. Classic Hummus 2. Lemon Hummus 3. Hummus with Cracked Chili Peppers 4. Hummus with Roasted Garlic 5. Scallion Hummus 6. Hummus with Roasted Red Peppers 7. Hummus with 40 Spices 8. Hummus with Calamata Olives 9. Hummus for Bagels 10. Hummus 11. Curry Hummus 12. Dill Hummus 13. Orange Hummus 14. Olive Hummus Sicilian Green 15. Olive Hummus Calamata Smooth 16. Olive Hummus Calamata Chunky 17. Olive Hummus French Nicoise 18. Olive French Picholine 19. Olive Hummus Moroccan Cured 20. Olive Hummus Greek Nafpelion 21. Baba Ganoush "Max Bean" label: 22. Hummus Oven Roasted Garlic 23. Hummus Mediterranean Classic 23. Hummus Roasted Red Pepper 24. Hummus Cucumber & Dill 25. Hummus Lemon & Black Pepper "Bruegger's" label: 26. Original Hummus. Recall #F-093/119-8. CODE "Use By" date up to and including "12 15 97": packed in 2 oz., 8 oz., 16 oz., and 64 oz., plastic containers. MANUFACTURER Rite Foods, Inc., Boston, Massachusetts. RECALLED BY Manufacturer, by fax on or about August 28, 1997, by telephone followed by fax on September 17, 1997, and by press release on September 17, 1997. Firm-initited recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON The product may be contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Fresh Marlin. Recall #F-090-8. CODE None. MANUFACTURER Inland Seafood, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone, followed by letter dated May 28, 1997. Firm-initiated recall complete. DISTRIBUTION Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia. QUANTITY Approximately 847 pounds were distributed. REASON Product contains excessive levels of histamine. _______________ PRODUCT Kroger Deluxe Ice Cream: a) Neopolitan Ice Cream; b) Neopolitan Fat Free Ice Cream. Recall# F-091/092-8. CODE a) Dec 31 97DL; b) 29 Nov 97ZC. MANUFACTURER a) Southern Ice Cream Specialties, Marietta, Georgia; b) Springdale Ice Cream and Beverage, Cincinnati, Ohio. RECALLED BY The Kroger Company, Cincinnati, Ohio, by telephone followed by E-Mail, on October 4, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia, Alabama, South Carolina, North Carolina, Indiana, Illinois, Missouri, Ohio, Kentucky, West Virginia, Michigan, Virginia, Tennessee. -2- QUANTITY a) 6,652 2-gallon containers; b) 23,728 2-gallon containers were distributed. REASON The product were processed from strawberry lots that were associated with an illness outbreak of Hepatitis A. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III =========== _______________ PRODUCT 100% Orange Juice From Concentrate packed in 64 fluid ounce paper cartons and 96 fluid ounce plastic jugs - some product contains pulp, distributed under the following labels: 1) America's Choice 100% Orange Juice From Concentrate, 64 fluid ounces distributed by Compass Foods Montvale, NJ 2) Best Yet 100% Pure Orange Juice From Concentrate, 64 ounces, packed for Scrivner, Inc. Oklahoma City, OK 3) Orchard Harvest 100% Juice Unsweetened Orange Juice From Concentrate, 64 fluid ounces, distributed by: BI-LO Inc., Mauldin, SC 4) Buehler's 100% Pure Orange Juice From Concentrate 64 fluid ounces, distributed by Buehler's Inc., Wooster, OH 5) FARMERS VALU Orange Juice From Concentrate, Net Weight 64 fluid ounces, distributed by H&H Sales Norcross, GA 6) Flavorite 100% Pure From Concentrate Orange Juice, 64 fluid ounces, distributed by Preferred Products, Inc., Eden Prairie, MN 7) Flavorite 100% Pure Old Fashioned With More Juicy Bits of Orange, from concentrate, 64 fluid ounces, distributed by Preferred Products, Inc. Eden Prairie, MN 8) Flavorite 100% Pure Orange Juice From Concentrate Unsweetened, 96 fluid ounces, distributed by Preferred Products, Inc., Chaska, MN 9) Food Club 100% Pure Orange Juice From Concentrate pulp added, 64 fluid ounces, distributed by Topco Associates, Inc., road, Skokie, IL 10) Food Club 100% Pure Orange Juice From Concentrate 96 fluid ounces, distributed by Topco Associates, Inc., Skokie, IL 11) Foodland 100% Orange Juice 64 fluid ounces, distributed by Preferred Products, Inc., Eden Prairie, MN 12) Four Winds 100% Pure Orange Juice From Concentrate 64 fluid ounces distributed by: Staff Supermarket Assoc., Inc., Norcross,GA -3- 13) Country Style Orange Juice From Concentrate High Pulp 64 fluid ounces, distributed by Staff Supermarket Associates, Inc., Norcross, GA 14) Four Winds Farm 100% Pure Orange Juice From Concentrate 96 fluid ounces, distributed by Staff Supermarket Associates, Inc., Norcross, GA 15) Great Value 100% pure Orange Juice from Concentrate 64 fluid ounces, marketed by Wal Mart Stores, Inc. Bentonville, AR 16) Great Value Orange Juice From Concentrate net 96 fluid ounces, marketed by Wal Mart Stores, Inc., Bentonville, AR 17) Hyde Park 100% Pure Orange Juice From Concentrate, 64 fluid ounces, distributed by Fleming Companies, Oklahoma City, OK 18) Harvey's Supermarkets 100% Orange Juice From Concentrate distributed by Harveys Supermarkets, Noashville, GA, 64 fluid ounces 19) Harvey's Supermarkets Country Style with more juicy bits of orange, 100% orange juice from concentrate, 64 fluid ounces, distributed by Harvey's Supermarkets, Nashville, GA 20) IGA Orange Juice 100% Pure From Concentrate 64 fluid ounces, distributed by IGA, Inc., Chicago, IL 21) IGA Country Style 100% Pure Orange Juice From Concentrate 64 fluid ounces, distributed by IGA, Inc. Chicago, IL 22) Janet Lee 100% Pure Orange Juice From Concentrate Unsweetened 96 fluid ounces distributed, by Albertson's Inc., Boise, ID 23) Janet Lee Country Style Orange Juice From Concentrate with juicy bits of orange distributed by Albertson's Inc. Boise, ID 24) Jus Squeezd 100% Orange Juice From concentrate 64 fluid ounces distributed by Lykes Pasco, Inc. Dade City, FL 25) Kash N Karry 100% Pure Orange Juice From Concentrate 64 fl ounces proudly distributed by: Kash 'N Karry Food Stores, Inc. Tampa, FL 26) Kingston 100% Pure Orange Juice From Concentrate 64 fluid ounces, packed for Kingston Marketing Co., Skokie, IL 27) Meijer 100% Pure Unsweetened Orange Juice From Concentrate 64 fluid ounces, distributed by Meijer, inc. Grand Rapids, MI 28) Meijer 100% Pure Unsweetened Orange Juice From Concentrate 96 fluid ounces, distributed by Meijer, Inc. Grand Rapids, MI -4- 29) Nature's Best 100% Pure Orange Juice From Concentrate 64 fluid ounces, distributed by Preferred Products, Inc. Eden Prairie, MN 30) Nature's Best 100% Pure Orange Juice Country Style with more juicy bits of orange, distributed by Preferred Products Inc. Eden Prairie, MN 31) Nature's Nectar 100% Pure Orange Juice From Concentrate, 64 fluid ounces, distributed by Aldi, Inc. Batavia, IL 32) Old South 100% Orange Juice From Concentrate, 64 fluid ounces, distributed by Lykes Pasco, Inc., Dade City, FL 33) Old South Country Style 100% Pure Orange Juice From Concentrate, 64 fluid ounces, distributed by Lykes Pasco, Inc., Dade City, FL 34) Old South 100% Pure From Concentrate Orange Juice, 96 fluid ounces distributed by: Lykes Pasco, Inc., Dade City, FL 35) Old Time 100% Pure Unsweetened Orange Juice From Concentrate 64 fluid ounces, distributed by Roundy's Inc., Milwaukee, WI 36) Our Family 100% Pure Orange Juice From Concentrate Unsweetened, 64 fluid ounces, distributed by Nash Finch Company Minneapolis, MN 37) Piggly Wiggly 100% Pure Orange Juice From Concentrate Unsweetened 64 ounces, distributed by Piggly Wiggly Corp., Memphis, TN 38) Red and White 100% Pure Orange Juice From Concentrate Unsweetened, 64 fluid ounces, packed for Federated Group Inc., Arlington Heights, IL 39) Seaway 100% Pure Orange Juice From Concentrate, net 64 fluid ounces, distributed by American Seaway Foods, Inc., Cleveland, OG 40) Shurfresh brand Orange Juice From Concentrate, 64 fluid ounces, distributed by Shurfine International Inc. Northlake, IL 41) Shurfresh brand Orange Juice From Concentrate, 64 fluid ounces, Country Style, distributed by Shurfine Int., Inc., Northlake, IL 42) Shurfresh Orange Juice From Concentrate, 96 fluid ounces, distributed by Shurfine International, Inc., Northlake, IL 43) Signal 100% Pure Orange Juice From Concentrate with added pulp, The Atlantic Signal Company, Inc. Stellarton, N-E BOK 1S0 44) Signal Pura 100% Jus D'Orange Avec Pulpe Ajoutee 1.89 L, The Atlantic Signal Company, Inc. Stellarton, N-E Box 1S0 -5- 45) Signal 100% Pure Orange Juice From Concentrate, 1.89L, The Atlantic Signal Company, Inc., Stellarton, N-E Box 1SO. 46) Signal Pura 100% Jus D'Orange, 1.89L, Atlantic Signal Company, Inc., Stellarton, N-E Box 1s0. 47) Spartan 100% Pure Orange Juice From Concentrate, 64 fluid ounces, distributed by Spartan Stores, Inc., Grand Rapids, MI 48) Spartan 100% Pure Orange Juice From Concentrate Unsweetened, 96 fluid ounces, distributed by Spartan Stores, Inc. Grand Rapids, MI 50) Utimate Choice Orange Juice From Cocncentrate, 64 fluid ounces, distributed by SSI, North Lake, IL 51) Western Family 100% Pure Orange Juice From Concentrate, 1.89 L Western Family Foods Vancouver, B.C. V684e4. 52) Western Family Jus D'Orange Fait de Concentrate 1.89L 53) Western Family 100% Pure Orange Juice From concentrate 1.89L, prepared for Western Family foods vancouver, b.C. 54) Jus D'Orange 100% Pur Fait de Concentrate 1.89L Recall #F-087-8. Code 08 OCT, 15 OCT, 22 OCT, 29 OCT, 05 NOV, 12 NOV, 19 NOV, 26 NOV. MANUFACTURER Lykes Pasco, Inc., Dade City, Florida. RECALLED BY Manufacturer, by telephone on September 24 and 29, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 350,000 cases were distributed. REASON The product is contaminated with yeast, exhibiting effervescence, and emitting an off odor. _______________ PRODUCT Pastry shells distributed in gift boxes labeled "Holiday Appetizers" which include 3 one-half pound Incredible Spreadable for filling the pastry shells (only the Croustades pastry shells are being recalled). Recall #F-088-8. CODE All product is being recalled. MANUFACTURER Pastry Shoppe Bakery, Glenwood, Minnesota. RECALLED BY Swiss Colony, Monroe, Wisconsin, by telephone during the period from October 3-5, 1997, and by mailgram and letter dated October 7, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 73 boxes of Croustades in 73 gift packs were distributed. REASON The product was packed under insanitary conditions. _______________ PRODUCT Pure Honey. Recall #F-089-8. CODE 075364-123153 (6.8 ounce bottles), 075364-123160 (25.3 ounce bottles). MANUFACTURER Robins Products, Hormigueros, Puerto Rico. RECALLED BY Manufacturer, by visit. Firm-initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY 150,000 6.8-ounce bottle and 5,000 25.3 ounce-bottles were distributed. REASON The product, falsely labeled as "Pure Honey", is adulterated as it was found to contain sugars of cane or corn origin. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT Platelets Pheresis. Recall #B-044-8. CODE Unit numbers: 535085, 535093, 535122 MANUFACTURER United Blood Services, Hot Springs, Arkansas. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter dated September 4, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 3 units were distributed. REASON Blood products either (1) tested repeat reactive for anti-HIV-1, Western Blot negative or (2) 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 Platelets, Pheresis. Recall #B-095-8. CODE Unit #3074513. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by letter dated December 23, 1996. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had sexual contact with someone who had lived in an HIV Group O risk area. _______________ PRODUCT Red Blood Cells. Recall #B-119-8. CODE Unit #18FQ20766. MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. -7- RECALLED BY Manufacturer, by telephone on July 29, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT a) Whole Blood; b) Red Blood Cells; c)Platelets; d) Fresh Frozen Plasma; e) Cryoprecipitated AHF; f) Plasma, Cryoreduced. Recall #B-120/125-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Products Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on February 26, 1997, March 3 or 21, 1997, and or by letters dated march 7 or March 21, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey and Pennsylvania. QUANTITY a) 8 units; b) 27 units; c) 1 unit; d) 6 units; e) 7 units; d) 4 units were distributed. REASON Blood products were incorrectly tested for CMV antibody. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-131/135-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated July 10, 11, 14, or 29, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky, Indiana, South Carolina. QUANTITY a) 27 units; b) 20 units; c) 8 units; d) 3 units; e) 19 units were distributed. REASON Blood products were collected from a donor taking the drug, Amantadine. ______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-148/149-8. CODE Unit #3144673. MANUFACTURER Florida Blood Services, Inc., Tampa, Florida. -8- RECALLED BY Manufacturer, by letter (fax) on April 29, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood products tested initially reactive for the antibody to the human immunodeficiency virus type 1-2 (anti-HIV 1-2) with no duplicate repeat testing performed. _______________ PRODUCT Platelets. Recall #B-152-8. CODE Unit #29444-9518. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter dated October 15, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood identified as a difficult draw. ________________ PRODUCT Red Blood Cells. Recall #B-156-8. CODE Unit #30001226. MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas. RECALLED BY Manufacturer, by telephone on November 21, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product tested negative for syphilis, but was collected from a donor who was deferred for testing positive for syphilis within one year of donation. _______________ PRODUCT Source Plasma. Recall #B-157-8. CODE Unit numbers: 72162033 and 72165782. MANUFACTURER American Biologicals, Inc., Waco, Texas. RECALLED BY Manufacturer, by fax on November 12, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 2 units were distributed. REASON Blood products tested negative for the HIV-1 p24 antigen, but were collected from a donor who previously tested repeatedly reactive for the HIV-1 p24 antigen. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-163/165-8. CODE Unit numbers: a) 10193-9811, 10204-9865 b) 10204-9865; c) 10193-9811. MANUFACTURER United Blood Services, Scottsdale, Arizona. -9- RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated August 25, 1997, and by fax on August 26, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona and Switzerland. QUANTITY a) 2 units; b) 1 unit; c) 1 unit was distributed. REASON Blood products were collected from a donor who had been deferred for intimate contact with a person who had hepatitis. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall # B-166/168-8. CODE Unit #29114-7854. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated September 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had been deferred for an accidental blood exposure. ______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-169/170-8. CODE Unit #20020-1063. MANUFACTURER United Blood Services, Lafayette, Louisiana. RECALL BY Blood Systems, Inc., Scottsdale Arizona, by letters dated July 30, 1997 and August 22, 1997. Firm-initiated recall complete. DISTRIBUTION Louisiana and Switzerland. QUANTITY 1 unit of each component was distributed. 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) Fresh Frozen Plasma c) Platelets. Recall #B-183/185-8. CODE Unit #03KL03714. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by telephone on October 11, 1996, and by letter on October 23, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. -10- REASON Blood product were collected form a donor with a history of hepatitis. ______________ PRODUCT Fresh Frozen Plasma. Recall # B-186-8. CODE Unit # 03V04270. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by telephone on December 26, 1996, and by letter on January 9, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of Red Blood Cells that was returned due to clotting. _______________ PRODUCT a) Red Blood Cells; b) Platelets, irradiated unit. Recall # B-187/188-8. CODE Unit #3KS03882. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by telephone on May 14, 1997 and by letter dated May 22, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were mislabeled as CMV antibody negative. _______________ PRODUCT Platelets. Recall # B-189-8. CODE Unit #03R01717. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by letter on September 19, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted Red Blood Cells. ______________ PRODUCT a) Platelets; b) Fresh Frozen Plasma. Recall #B-190/191-8. CODE Unit #03R02085 MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by letter on September 18, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component. -11- REASON Blood product corresponded to a unit of clotted Red Blood Cells. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Frozen Plasma. Recall #B-192/195-8. CODE Unit numbers: a) KE56032, KQ27938, b) KE56032; c) KE56032; d) KQ27038. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone and by letter dated August 3, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia and California. QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-196/198-8. CODE Unit #KN11462. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated July 28, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-126/128-8. CODE Unit numbers: a) units 49FM27056, 49LF32126, 49LF32143, 49LK07336, 49W19289, 49W19661 b) 49W19661; c) 49FM27056, 49LF32126, 49W19289, 49W19661, 49LF32143. MANUFACTURER American Red Cross Blood Services, Waco, Texas. RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma, by letters dated June 19, 1997, and by letter dated July 18 and 30, 1997. Firm-initiated recall complete. DISTRIBUTION Texas, Oklahoma, California, Massachusetts, Switzerland. QUANTITY a) 6 units; b) 1 unit; c) 5 units were distributed. REASON Blood products were collected from donors with no documentation that the arm inspection was performed. -12- _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-129/130-8. CODE Unit #18FS06345. MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. RECALLED BY Manufacturer, by letters dated April 10 and 16, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who had no arm inspection documented. _______________ PRODUCT Red Blood Cells. Recall #B-139-8. CODE Unit #10508-1323. MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona. RECALLED BY Manufacturer, by telephone on March 18, 1996. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product was not tested for the E antigen was labeled E negative. _______________ PRODUCT Washed Red Blood Cells. Recall #B-140-8. CODE Unit numbers: 3031060 and 3077935. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by telephone on February 21, 1997, and by letter dated September 3, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 2 units were distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-141-8. CODE Unit numbers: 26149-7757, 26149-7758, 26149-7759, 26149-7761, 26149-7763, 26149-7766, 26149-7767, 26149-7769, 26149-7771, 26149-7772, 26149-7773, 26149-7775, 26149-7776, 26149-7777, 26149-7780. MANUFACTURER United Blood Services, Fort Smith, Arkansas. RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by telephone on August 22, 1997, and by letter on October 6, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 15 units were distributed. -13- REASON Blood products were not frozen within eight hours of whole blood collection. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-144-8. CODE Unit #10506-6732. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 16, 1996. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood with an extended collection time. _______________ PRODUCT Recovered Plasma. Recall #B-145-8. CODE Unit #18FS06047. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by letter on April 8, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood products corresponded to a unit of Red Blood Cells that was returned due to clotting. _______________ PRODUCT Platelets. Recall #B-154-8. CODE Unit numbers: 16LS22449, 16LW16009, 16LY30428, 16LL27089, 16LW16003. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by telephone on August 20, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 5 units were distributed. REASON Blood products were stored at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-155-8. CODE Unit #13000279. MANUFACTURER W.E. and Lela I Stewart Blood Center, Inc., Tyler, Texas. RECALLED BY Manufacturer, telephone on November 5, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose health history screening was inadequately performed. -14- _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-176/178-8. CODE Unit #17181-6785. MANUFACTURER United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated August 26, 1997. Firm-initiated recall complete. DISTRIBUTION Texas and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for syphilis, but were collected from a donor who previously tested reactive for syphilis on two occasions. _______________ PRODUCT Washed Irradiated Red Blood Cells. Recall #B-201-8. CODE Unit numbers 26150-6977 and 26150-7198. MANUFACTURER United Blood Services, Fort Smith, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 2, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 2 units were distributed. REASON Blood products were labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========== _______________ PRODUCT Horizon/Horizon Modular Nxt Infusion Pumps. Recall #Z-039/040-8. CODE Various serial numbers. MANUFACTURER B.Braun McGaw Medical, Carrollton, Texas. RECALLED BY Manufacturer, by letter on October 14, 1997. Firm-initiated recall ongoing. DISTRIBUTION Kansas, Pennsylvania, Virginia, California, Georgia, Massachusetts, New Jersey, Nevada, Montana, Florida. QUANTITY 391 pumps were distributed. REASON The detection air-in-line pump could not consistently alarm when a .1 ml air bubble is passed through the pump for infusion rates greater than 350 ml/hr. _______________ PRODUCT EZ-Flow 480 Ambulatory Infusion Pump. Recall #Z-047-8. CODE All serial number with software version 2.3. MANUFACTURER Gish Biomedical, Inc., Irvine, California. RECALLED BY Manufacturer, by fax on September 30, 1997, October 1 and 2, 1997. Firm-initiated field correction ongoing. -15- DISTRIBUTION Nationwide. QUANTITY 1,058 devices of all serial numbers. REASON Defective software may cause over infusion when using the PCA mode _______________ PRODUCT a) TAS PT Test Card; b) TAS PT-ONE Test Card, especially suited for professional use in decentralized areas of tsting near the site of patient case, as well as for use in the more traditional clinical laboratory. Recall #Z-166/167-8. CODE a) Catalog #1001, Lot Nos. 302069701, 302079701, 302079702, 302079703, and 302079704 b) Catalog #1018, Lot Nos. 30101701, 30101702, 30101703, 30102701, 30102702, 30102703, 30102704, 301049703, 301049704, 302049705, 301049706, 301059701, 301069701, 301079701, 301079703, 301079705, and 301079706. MANUFACTURER Cardiovascular Diagnostics, Inc., Raleigh, North Carolina. RECALLED BY Manufacturer, by letter on September 17 and 23, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY a) 562 units; b) 1,837 units were distributed. REASON A change in the test instructions in a technical bulletin included incorrect mean normal prothrombin times and these values could produce incorrect International Normalized Ratio results. _______________ UPDATE King Systems Ultra-Flex Adult Anesthesia Breathing Circuits which appeared in the November 5, 1997, Enforcement Report as Recall #Z-049/153-8, is being changed to Recall #Z-049/-152-8. (Z-153-8 will be reassigned to another recall.) The following are corrections to the listing of the various product recalls: Product 5213F-6154 should be product 51213F-6154. Product 5613B-80X. Lot 06737H7 should be lot 0637H7. Product 61213F-6154 should be product 51213F-6154. Product 6753F-61. Add lot 1560G7. Product 8412B-61. Lot 01416G7 should be 1416G7. Product 8613B-61. Lot 0887G7 should be 0887H7. Product 8613F-61. Add lot 0614G7 and Delete lot 1360G7. -16- Product 8613F-61X. Delete lot 0614G7. Product 8613F-164E. Add lot 1360G7. Product 8613F-84 should be product 8613F-80. Product 8753B-61. Add lot 0505F7. Product 90316. Add lot 0262J7. Product 90353. Lot 507F7 should be 1507F7. -17- END OF ENFORCEMENT REPORT FOR NOVEMNER 19, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for