December 4, 1996 96-49 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Various flavored ice cream as follows: (a) Chocolate Marshmallow packed in pint containers, half gallon cartons and 2 1/2 gallon tubs (b) Heavenly Hash packed in half gallon cartons and 2-1/2 gallon tubs (c) Mint Chip packed in 2 1/2 gallon tubs. Recall #F-113/115-7. CODE None. MANUFACTURER Mercer's Dairy, Inc., Boonville, New York. RECALLED BY Manufacturer, by press release and letter on October 17, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY Undetermined. REASON The product's labels fail to declare allergens that may pose a potential hazard to sensitive individuals: (a) contains undeclared egg albumen; (b) contains undeclared egg albumen and peanuts; (c) contains undeclared egg yolks. RECALLS AND FIELD CORRECTIONS: FOODS CLASS II ============== _______________ PRODUCT Various flavored dry seasonings. Recall #F-079/112-7. CODES 1. Frontier All-Purpose Seasoning, 16-oz. bag and 400 oz. (25-lb. box) 6131, 6177, 6239 (after 5/10/96) 6239 (after 8/26/96) 2. Frontier Saltless All Purpose Seasoning, 6131, 6177 1.28-oz. glass bottle (after 5/10/96) 3. Canadian-labeled Frontier Saltless All Purpose Seasoning, 1.28-oz. glass bottle 6131 (after 5/10/96) 4. Frontier Bouquet Garni, 16-oz. bag 6256 (after 9/12/96) 5. Frontier Cajun Seasoning, 16-oz. bag 6162, 6225, 6248 (after 6/10/96) and 400 oz. (25-lb. box) 6. Oak Street Market Gourmet Cajun Seasoning, 2.08-oz. glass bottle 6173, 6225 (after 6/21/96) 7. Frontier Cheese & Italian Herb Seasoning, 16-oz. bag 6229 (after 8/16/96) 8. Frontier Wellspring Grocery Greek Lamb Sausage, 3.5 oz. (6183) 9. Frontier Ground Gumbo File, 16-oz. bag 6208 (after 7/26/96) 10. Frontier Herbs de Provence, 16-oz. bag 6220, 6255 (after 8/7/96) and 25-lb. box 6249, 6255 (after 9/5/96) 11. Canadian-labeled Frontier Non-Irradiated Herbs de Provence, 0.8-oz. glass bottle 6220 (after 8/7/96) 12. Frontier Non-Irradiated Herbs de Provence, 0.8-oz. glass bottle 6220 (after 8/7/96) 13. Oak Street Market Gourmet Herbs de Provence, 0.8-oz. glass bottle 6220 (after 8/7/96) 14. Whole Foods Herbs de Provence, 0.8 oz. 6220 (after 8/7/96) 15. International Seasonings Herbs de Provence, 0.8-oz. glass bottle 6220 (after 8/7/96) 16. International Seasonings Herbs of Italy, 0.8-oz. glass bottle 6151, 6212 (after 5/30/96) 17. Frontier Ground Italian Seasoning, 16-oz. bag 6187, 6221 (after 7/5/96) 18. Frontier Whole Italian Seasoning, 16-oz. bag 6121, 6129, 6150, 6171, 6197, 6264 (after 4/30/96) and 25-lb. box -2- 19. Frontier Non-Irradiated Italian Seasoning, 0.96-oz. foil pouches 6129 (after 5/8/96) 20. Frontier Saltless Italian Seasoning, 0.8-oz. glass bottle 6129, 6171, 6197 (after 5/8/96) and 1.04-oz. glass bottles 6176 (after 6/24/96) 21. Frontier Pizza Seasoning, 16-oz. bag 6155, 6162, 6184, 6198, 6240 (after 6/3/96) and 400-oz. (25-lb. box) 6162, 6184, 6198 (after 6/10/96) 22. Frontier Non-Irradiated Poultry Seasoning, 1.44-oz. glass bottle 6187, 6254 (after 7/5/96) 23. Canadian-labeled Frontier Non-Irradiated Poultry Seasoning, 1.44-oz. glass bottle 6254 (after 9/10/96) 24. Frontier Ground Poultry Seasoning, 16-oz. bag 6187 (after 7/5/96) 25. Oak Street Market Gourmet Poultry Seasoning, 1.44-oz. glass bottle 6187, 6254 (after 7/5/96) 26. Whole Foods Poultry Seasoning, 1.44 oz. 6187 (after 7/5/96) 27. Frontier Cut & Sifted Thyme Leaf, 16-oz. bag 6109, 6141, 6218 (after 4/18/96) and 25-lb. box 6141 (after 5/20/96) 28. Frontier Non-Irradiated Cut & Sifted Thyme Leaf, 0.8-oz. foil pouches 6109, 6218, (after 4/18/96) 29. Canadian-labeled Frontier Non-Irradiated Cut & Sifted Thyme Leaf, 0.64-oz. glass bottle 6109 (after 4/18/96) 30. Oak Street Market Gourmet Cut & Sifted Thyme Leaf, 0.64-oz. glass bottle 6109, 6218, (after 4/18/96) 31. Whole Foods Wild Spanish Thyme, 0.64 oz. 6109, 6218 (after 4/18/96) 32. Frontier Ground Thyme Leaf, 16-oz. bag 6129, 6190 (after 5/8/96) 33. Frontier Nettles Eyebright Formula Bulk Herb Capsules, 300 Vegicaps (400 mg) in a foil pouch 6185 (after 7/3/96) 34. Frontier Nettles Eyebright Formula 100 Vegicaps (400 mg) in a glass jar 6185 (after 7/3/96). MANUFACTURER Frontier Cooperative Herbs, Norway, Iowa. RECALLED BY Manufacturer, by telephone on October 4, 1996, followed by letter on October 5, 1996. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY Undetermined. REASON Product is contaminated with Salmonella. -3-_______________ PRODUCT Mercer's brand ice cream: (a) Butter Brickle packed in 2 1/2 gallon tubs (b) Pistachio packed in 2 1/2 gallon tubs. Recall #F-116/117-7. CODE None. MANUFACTURER Mercer's Dairy, Inc., Boonville, New York. RECALLED BY Manufacturer, by press release and letter on October 17, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY Undetermined. REASON Products contain undeclared almonds. _______________ PRODUCT Quaker FrescAvena Oats Beverage Mix, Cinnamon Flavor in 17.6 oz. (500g) plastic canisters 24 per case. Recall #F-121-7. CODE Canister lot #10G6C7, Case Code JUL 10 96. MANUFACTURER The Quaker Oats Co., Valencia, Venezuela. RECALLED BY The Quaker Oats Company, Chicago, Illinois, by telephone on September 26, 1996. Firm- initiated recall ongoing. DISTRIBUTION New Jersey, New York, Connecticut, Massachusetts. QUANTITY 127 cases were distributed; firm estimated that 30 percent of product remained on market at time of recall initiation. REASON Product is unfit for food due to the presence of pieces of hot-melt adhesive. _______________ PRODUCT Kellogg's Frosted Flakes, in 25 ounce boxes. Recall #F-122-7. CODE "Better If Used Before" date of "June 08, 1997 MA" printed on the boxtop. MANUFACTURER Kellogg Company, Memphis, Tennessee. RECALLED BY Kellogg Company, Battle Creek, Michigan, by press release on August 6, 1996. Firm- initiated recall complete. DISTRIBUTION Texas. QUANTITY Approximately 1,440 cases containing 16 boxes each were in commerce at time of recall initiation. REASON Product contains undeclared almonds. _______________ PRODUCT La Colonial Sweet Bread, packaged in 10 ounce plastic bags. Recall #F-123-7. CODE All lots. MANUFACTURER La Colonial Bakery, Dallas, Texas. -4-RECALLED BY Manufacturer, by visit on or about September 27, 1996. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Texas. QUANTITY 400 packages were distributed. REASON Product contains undeclared FD&C Yellow No. 5. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Minute Maid Apple Juice, in 9 pack and 8.45 ounce packages. Recall #F-120-7. CODE Container Codes - JAN1997TE, JAN1997TF, JAN1997TG, JAN1997TH; Case Code - Lot number T30922F. MANUFACTURER Coca Cola Foods, Paw Paw, Michigan. RECALLED BY Coca Cola Foods, Houston, Texas, by visit on June 3, 1996. Firm-initiated recall ongoing. DISTRIBUTION Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Nebraska, Ohio, Virginia, Wisconsin, West Virginia. QUANTITY 12,772 cases were distributed. REASON Product is unfit for food due to swells, spoilage, and leaking containers. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT MPI MAA Kit, for the preparation of Technetium Tc 99m Albumin Aggregated Injection, in multidose vials containing 2.5 mg albumin aggregated, 5.0 mg albumin human, 0.06 mg stannous chloride, and 1.2 mg sodium chloride. Recall #D-046-7. CODE Lot numbers: V-1298 EXP OCT 04 96, V-1381 EXP FEB 07 97, W-0069 EXP FEB 21 97 W-0289 EXP MAR 21 97. MANUFACTURER Merck Frosst Canada, Inc., Quebec, Canada. RECALLED BY Medi-Physics, Inc., an Amersham company, Arlington Hts., Illinois (own label distributor), by telephone on November 12, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Hong Kong. QUANTITY 2,423 kits were distributed; firm estimated that very little, if any, product remained on market at time of recall initiation. REASON Lack of adequate assurance of sterility of the human albumin component manufactured by Centeon, Kankakee, Illinois. -5-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Congess SR, packaged in bottles of 100, Rx decongestant. Recall #D-047-7. CODE Lot #6041479 EXP 2-97. MANUFACTURER Fleming & Company, Fenton, Missouri. RECALLED BY Manufacturer, by telephone on November 18, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 800 bottles were distributed. REASON FDA analysis found this lot failed the release rate test -- the 4th hour release interval for Pseudoephedrine was found to be 90%; the specification is not more than 88%. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-549/550-6. CODE Unit #40FS03901. MANUFACTURER American Red Cross, Peoria, Illinois. RECALLED BY Manufacturer, by letter dated October 3, 1995. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit of each component was distributed. REASON Blood products tested initially reactive for anti-HIV, units then tested into compliance with no confirmatory test. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-551/552-6. CODE Unit #47C47842. MANUFACTURER American Red Cross, Peoria, Illinois. RECALLED BY Manufacturer, by letter dated March 18, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois and Iowa. QUANTITY 1 unit of each component was distributed. REASON Blood products tested initially reactive for anti-HIV, units then retested only once with no confirmatory testing. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Electric Mat Tables, Model SWM1-5E. Recall #Z-131-7. CODE Serial numbers: 0201-M4E-331-3, 0201-M5E-334-5, 0201-M3E-336 0212-M4E-337, 0212-M5E-338 0212-M3E-339. -6-MANUFACTURER S & W Enterprises, Inc., Blaine, Minnesota. RECALLED BY Manufacturer, by telephone on February 1, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 9 mat tables were distributed. REASON When the flexible coupler was used to move the table up and down, the motor continued to run, but the table height did not change. _______________ PRODUCT Baxa Model 60001, Dual Rate Syringe Infusers, used for the administration of IV drugs. Recall #Z-132-7. CODE Serial numbers: 2001 through 2089 2122 through 2181 2194 through 2264 2266 through 2365 2367 through 2438. MANUFACTURER Baxa Corporation, Englewood, Colorado. RECALLED BY Manufacturer, by telephone on August 23, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 392 units were distributed. REASON The device has the potential to run at twice the speed for which it is set. _______________ PRODUCT EZ Flow 480 Ambulatory Infusion Pumps containing software versions 2.2c or earlier. Recall #Z-133-7. CODE Various serial numbers with software version 2.2c or earlier. MANUFACTURER Gish Biomedical, Inc., (formerly Creative Medical Developments, Inc. (CMD)), Nevada City, California. RECALLED BY Manufacturer, by telephone on February 23, 1996 and March 1 and 18, 1996. Follow-up letters were sent on June 11, 1996 and August 2, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 577 units were distributed. REASON Due to a software error, the EZ-480 exhibits a faulty infusion rate when placed in the pause mode and subsequently restarts. _______________ PRODUCT Devon Point of Use Cabinet: (a) Model Reorder No. 4842; (b) Model Reorder No. 4844, an accessory to the Devon Point of use Sharps-a- Gator. Recall #Z-140/141-7. CODE All lots. -7-MANUFACTURER Graphic Controls (Devon Industries), Chatsworth, California. RECALLED BY Graphic Controls Corporation, Buffalo, New York, by visit and by letters dated August 26, 1996, and September 4, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY (a) 10,840 cabinets; (b) 2,580 cabinets were distributed. REASON The solid color of the door of the sharps container cabinet may affect the ability of the user to determine the fill level of the needles and syringes allowing for the potential of needlestick injuries. _______________ PRODUCT X-Ray Generator, Model No. CP700. Recall #Z-142-7. CODE All units. MANUFACTURER Gendex-Del Medical Imaging Corporation, Franklin Park, Illinois. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on November 20, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Noncompliance with performance standards for x-ray products in that selection of one of the 3,072 possible selectable exposure conditions failed to meet the firm's accuracy claim for mAs selection. _______________ PRODUCT Stainless Steel Greenfield Vena Cava Filter with 12 French Introducer System, a permanently implanted device designed to protect against pulmonary embolism while maintaining patency of the vena cava. Recall #Z-146-7. CODE Catalog #50-400. All lots. MANUFACTURER Boston Scientific Corporation, Watertown, Massachusetts. RECALLED BY Boston Scientific Corporation, Natick, Massachusetts, by letters on April 29, 1996, and October 26, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 4,898 devices were distributed. REASON The guidewire can become wedged in the apex of the vena cava filter using the jugular approach. -8-_______________ PRODUCT Opus Rubella Test Modules and Opus Rubella-M Test Modules: (a) OPUS* Rubella Test Modules, Catalog No. 464-050, (b) OPUS* Rubella-M Test Modules (Foreign Distribution), Catalog No. OWUX/25 and OWUX/45. Recall #Z-148/149-7. CODE Lot numbers: (a) Lot Nos. RBC6, RBC9, RBD3, RBD4, RBD5, RBD6; (b) RMC8, RMC9. MANUFACTURER Behring Diagnostics, Inc., Westwood, Massachusetts. RECALLED BY Manufacturer, by telephone on October 29, 1996, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Quantity estimated in distribution: RBC6 5 boxes; RBC9 11 boxes RBD3 13 boxes; RBD4 26 boxes RBD5 39 boxes; RBD6 72 boxes RMC8 2 boxes; RMC9 54 boxes. REASON Negative control yielded indeterminate results, and there was a high incidence of false positive test results. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Condylar Bone Screws, Catalog #CS027-08/10. Recall #Z-145-7. CODE Lot #2076. MANUFACTURER Komet Medical, Savannah, Georgia (supplier of screws). RECALLED BY TMJ Implants, Inc., Golden, Colorado, by telephone, followed by letter sent by fax on October 7, 1996. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, Tennessee, Texas. QUANTITY 8 packages of 7 screws each were distributed. REASON Some Condylar Bone Screws were in packages labeled as Fossa-Eminence Bone Screws, and some Fossa-Eminence Bone Screws were incorrectly labeled as Condylar Bone Screws. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ====== _______________ PRODUCT Steward Custom Mix Calf Feed - Medicated in 50 pound bags (amprolium and rabon). Recall #V-022-7. CODE Product Code: 3447-12, Lot numbers J207 and J249. MANUFACTURER Cargill, Inc., Nutrena Feed Division, Memphis, Tennessee. -9-RECALLED BY Cargill Feed Division, Wayzata, Minnesota, by telephone on September 16, 1996. Firm- initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 540 bags were distributed. REASON Product was subpotent in amprolium/rabon. -10- END OF ENFORCEMENT REPORT FOR DECEMBER 4, 1996. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for