December 10, 1997 97-50 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Danish Bakery Larsens Pumpkin Muffins in hard clear plastic cellophane containers, 16 ounces. Recall #F-134-8. CODE Pull dates 11-5 through 11-9 inclusive. MANUFACTURER Larsen Brothers Danish Bakery, Lynwood, Washington. RECALLED BY Manufacturer, by telephone on November 5, 1997. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY Approximately 25 packages 4 muffins per package were distributed. REASON Product contained undeclared walnuts. _______________ PRODUCT Cream Cheese and Vegetables packed in plastic 8 ounce cups for retail use, and 8 pound buckets for bulk use. Recall #F-136-8. CODE All codes. MANUFACTURER Rite Foods, Inc., Boston, Massachusetts. RECALLED BY Manufacturer, by telephone on October 30, 1997, followed by fax, and by press release on October 31, 1997. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Connecticut, New Hampshire, Rhode Island, Maine, Vermont, New York, New Jersey, Pennsylvania. QUANTITY Approximately 990 cases (12 8-ounce containers) and 300 8-pound buckets were distributed. REASON Product may be contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Margarine/spread under the following labels: 1. Country Crock 12 pack case of 3 lb. tubs; 12 pack case of 1 1/2 lb. tubs; 24 pack case of 1 lb. tubs; 6 pack case of 5 lb. tubs; 18 pack case of 2 lb. 8 oz. tubs 2. Country Crock Light 12 pack case of 3 lb. tubs 3. Country Crock Churnstyle 12 pack case of 3 lb. tubs 4. I Can't Believe It's Not Butter! Six pack case of 3 lb. tubs; 24 pack case of 1 lb. tubs; 18 pack case of 2 lb. 8 oz. tubs 5. Imperial 6 pack case of 3 lb. tubs 6. I Can't Believe It's Not Butter! Squeeze 18 pack case of 16 oz. bottles 7. Promise Light 24 pack case of 2 lb. 8 oz. tubs 8. Buttermatch 6 pack case of 3 1/2 lb. tubs 9. Kroger 6 pack case of 3 lb. tubs 10. Albertson's Butter 18 pack case of 1 lb. tubs 11. Great Value 12 pack case of 2 lb. tubs; 6 pack case of 3 lb. tubs 12. Hy-Top 6 pack case of 3 lb. tubs 13. Janet Lee 6 pack case of 3 lb. tubs 14. Morning Fresh 6 pack case of 3 lb. tubs 15. Publix 6 pack case of 3 lb. tubs 16. Albertson's 18 pack case of 1 lb. tubs 17. Shedd's 6 oz. mug 18. Shedd's Liquid 2 1/4 lb. bottle 19. Shedd's Garlic Spread 12 pack case of 1 lb. tubs 20. Shedd's Whip 20 lb. tub 21. Monarch Whip 20 lb. tub 22. Sysco Whip 20 lb. tub 23. Filberts Stick 30 pack case of 1 lb. Quarters 24. I Can't Believe It's Not Butter! 30 pack case of 1 lb. Quarters 25. Quarters -2- 26. Country Crock 30 pack case of 1 lb. Quarters 27. Country Crock Churnstyle 30 pack case of 1 lb. Quarters 28. Shedd's Spread 30 pack case of 1 lb. Quarters 29. Better Value 30 pack case of 1 lb. tubs 30. Blue Ribbon 30 pack case of 1 lb. tubs 31. Albertson's 30 pack case of 1 lb. Quarters 32. Albertson's 30 pack case of 50 lb. Quarters 33. Publix 30 pack case of 1 lb. Quarters 34. Filberts 8 pack case of 6 lb. tins 35. NIFDA 30 pack case of 1 lb. Solids 36. Nugget 30 pack case of 1 lb. Solids 37. Pocahontas 30 pack case of 1 lb. Solids 38. All Kitchen 30 pack case of 1 lb. Solids 39. Blue Ribbon 30 pack case of 1 lb. Solids 40. Frosty Acres 30 pack case of 1 lb. Solids 41. Shedd's 30 pack case of 1 lb. Solids 42. Country Crock 5 gm 43. Country Crock 14 gm 44. Blue Ribbon 5 gm 45. Sysco Farm Fresh 5 gm, 14 gm 46. Country Crock and Honey 10 gm 47. Promise 5 gm. Recall #F-139/185-8. CODE Date Codes DEC1697A, DEC1797A, and DEC1897A. MANUFACTURER Lipton Foods, Atlanta, Georgia. RECALLED BY Manufacturer, by fax on June 26, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Florida, Indiana, Kentucky, Massachusetts, North Carolina, Pennsylvania, Ohio, South Carolina, Tennessee, Virginia, Puerto Rico. QUANTITY 51,798 cases were distributed. REASON The products were processed under insanitary conditions whereby they may become injurious to health. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Great Value brand Frozen Concentrated Orange Juice, in 12 fluid ounce plastic "cans". Recall #F-135-8. CODE B7210. MANUFACTURER Citrus Belle, LaBelle, Florida. RECALLED BY Manufacturer, by telephone on September 29, 1997. Firm-initiated recall ongoing. DISTRIBUTION Midwest and Southeast United States. QUANTITY Approximately 63,000 units were distributed. REASON Product is contaminated with sand. -3- _______________ PRODUCT Izalco Cebada Rosada (Pink Barley Drink Mix), in 12 ounce containers. Recall #F-137-8. CODE None. MANUFACTURER Abeco Alimentos & Bebidas, La Libertad, El Salvador. RECALLED BY Cacique Foods, Inc., Jersey City, New Jersey, by letter dated August 20, 1997. Ongoing recall resulted from sample analysis and followup by the New York Department of Agriculture and Markets. DISTRIBUTION Nationwide. QUANTITY Approximately 100 cases (24 packages per case) were distributed; firm estimated that 10 percent of product remained on market at time of recall initiation. REASON Product contains undeclared FD&C Red No. 40 and Red No. 3. ______________ PRODUCT Ferrara brand Grenadine Syrup packed in 26.4 fluid ounce plastic bottles with white plastic screw on caps. Recall #F-138-8. CODE None. All product distributed 6/96 through 1/97. MANUFACTURER Colavita USA, Inc., Linden, New Jersey. RECALLED BY Manufacturer, by letter February 18, 1997. Firm-initiated recall complete. DISTRIBUTION New York and New Jersey. QUANTITY 85 cases (1,020) units were distributed; firm estimates none remains on the market. REASON Product contained undeclared FD&C Red No. 40. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT a) Red Blood Cells b) Red Blood Cells-Leukocytes Removed c) Platelets; d) Fresh Frozen Plasma. Recall #B-262/265-8. CODE Unit numbers: a) 10491-6125, 10506-3479 b) 10502-1846; c) 10502-1846, 10506-3479 d) 10491-6125. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 9, 1996, and January 15, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. -4- QUANTITY a) 2 units; b) 1 unit; c) 2 units; d) 1 unit was distributed. REASON Blood products were collected from a donor whose health history screening was inadequately performed. _______________ PRODUCT Red Blood Cells. Recall #B-281-8. CODE Unit #KR96959. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter dated June 6, 1997. Firm-initiated recall complete. DISTRIBUTION Iowa. 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 Red Blood Cells. Recall #B-282-8. CODE Unit #LC21805. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by telephone on March 26, 1997. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was not tested for syphilis. _______________ PRODUCT Platelets. Recall #B-286-8. CODE Unit #KE53960. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by telephone and by letter dated July 20, 1993. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but was collected from a donor who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT Red Blood Cells. Recall #B-287-8. CODE Unit #KT85533. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. -5- RECALLED BY Manufacturer, by letter dated June 6, 1997. Firm-initiated recall complete. DISTRIBUTION Iowa. 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) Recovered Plasma. Recall #B-289/290-8. CODE Unit #8144243. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by letter dated September 20, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tattoo within 12 months of donation. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-291/292-8. CODE Unit #7833339. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by letter dated September 24, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who was exposed to blood of two different people. _______________ PRODUCT Platelets. Recall #B-293-8. CODE Unit #24FH11763. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by telephone on September 11, 1997, and by letter dated November 14, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Recovered Plasma. Recall #B-266-8. CODE Unit # 10502-1846, 10506-3479. MANUFACTURER United Blood Services, Scottsdale, Arizona. -6- RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter on July 9, 1996. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 2 units were distributed. REASON Blood product was collected from a donor whose health history screening was inadequately performed. _______________ PRODUCT Red Blood Cells. Recall #B-288-8. CODE Unit #KC94403. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by telephone on May 30, 1996. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Concentrate Bicarbonate Dialysate, labeled for use only with acid concentrate solution in a 3-stream proportioning artificial kidney equipment using Purified Water (AAMI Standard RD5). Recall #Z-205-8. CODE Lot numbers 714043C and 716341C. MANUFACTURER Gambro Healthcare, DeLand, Florida. RECALLED BY Manufacturer, by letter mailed on August 30, 1997. Firm-initiated recall ongoing. DISTRIBUTION Florida, Pennsylvania, New York, Tennessee, Georgia, Ohio, New Jersey, Iowa, Massachusetts, California, South Carolina, Virginia, North Carolina, Kansas, Texas, Nebraska. QUANTITY 933 cases were distributed. REASON The bags are mislabeled as "BP-001-15"(product which yields 15 gallons of liquid bicarbonate) when in fact the bags contain "BP-001-25" (product which yields 25 gallons of liquid bicarbonate). _______________ PRODUCT B & F Medical Disposable Home Ventilator Circuits, used in conjunction with Life Products and Lifecare Ventilators, to provide respiratory therapy for individuals receiving in-home patient care: a) Model No. 64673; b) Model No. 64677; c) Model No. 64693; d) Model No. 64694; -7- e) Model No. 64698; f) Model No. 64699. Recall #Z-206/211-8. CODE The recalled ventilator circuits are identified with six digit lot numbers, the first four digits of which are: 2747 through 3047. MANUFACTURER Allied Healthcare Products, Inc., doing business as, B & F Medical Products, Disposable Products Division, Toledo, Ohio. RECALLED BY Manufacturer, by letter on November 11, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 7,230 circuits were distributed. REASON The devices may have small particles of polyethylene plastic in the exhalation valve connector tee. SEIZURES: ================================================= _______________ PRODUCT Frozen Shrimp (97-768-221). CHARGE Adulterated -- Decomposition. LOCATION Americold Corporation, Tampa, Florida. FILED November 26, 1997 - U.S. District Court for the Middle District of Florida, Tampa Division; Civil No. 97- 2826-CIV-T-26C, FDC 67215. SEIZED November 26, 1997 -- 555 cases valued at $30,000. _______________ PRODUCT Liquid Oxygen USP stored in a bulk stand tank and in cryogenic vessels and home units (DOC 97-557-804). CHARGE Adulterated -- good manufacturing practice violations. Misbranded -- labels fail to bear adequate directions for use and the prescription legend, "Caution: Federal law prohibits dispensing without prescription." LOCATION Praxair Distribution, Inc., Mankato, Minnesota. FILED October 16, 1997 - U.S. District Court for the District of Minnesota; Civil No. 97-2310; FDC 67207. SEIZED October 22, 1997 - Goods valued at $95,468. -8- END OF ENFORCEMENT REPORT FOR DECEMBER 10, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for