The FDA Enforcement Report is published weekly by the Food and DrugAdministration,U.S. Public Health Service, Department of Health and Human Services. It containsinformationon actions taken in connection with agency regulatory activities.
ENFORCE02/01/1995 Recalls and Field Corrections: Foods -- Class I -- 02/01/1995 February 1, 1995 95-5 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I========================== _______________PRODUCT Various salads and cut vegetables. The salads are packaged in 10-lb. plastic buckets with "SCHUH SALADS 1422 Montgomery St. St. Louis, MO 63106" printed on the container and lid. Some salads are packed in 5-lb. plastic buckets that are plain with no printing with a sticker applied bearing the name of the product and the ingredients. The School Salad is packed in 30-lb. plastic bags inside a shipping carton. Some salads are packed in individual 3-, 4-, and 4.5-oz. serving sizes. The precut vegetables are available in 1-, 2-, 2.5-, 3-, 5-, 10-, 15-, 20-, 25-, and 30-lb. units. They are usually packaged in vacuum-packed bags but sometimes are packaged in plastic buckets: Recall #F-196/307-5. 1. Ambrosia 2. Baked Beans 3. Beet N Onion 4. Carrot N Raisin 5. Cheese Cake 6. Corn Relish 7. Cranberry Relish 8. Creamy Cole Slaw 9. Cucumber Salad 10. Dill Potato Salad 11. Egg Salad 12. French Pasta Salad 13. Garden Salad 14. Spaghetti Salad 15. German Potato Salad 16. Greek Salad 17. Italian Pasta Salad 18. Macaroni Salad 19. Marinated Carrots 20. Marinated Mushrooms 21. Mayonnaise Potato 22. Mustard Potato Salad 23. School Salad 24. Old-Fashioned Red Potato Salad with Egg 25. Ranch Potato Salad 26. Sante Fe Potato 27. Seafood Pasta 28. Shells N Cheddar 29. Parmesan Pasta 30. Southwestern Pasta 31. Sweet N Sour Slaw 32. Three Bean Salad 33. Tortellini Salad 34. Tuna Salad 35. Waldorf Salad 36. Apples, diced 37. Apples, diced w/skin 38. Apples, whole peeled 39. Apples, whole peeled halved 40. Apples, sliced 41. Broccoli, flowers and spears 42. Shredded Red Cabbage 43. Cantaloupe, chunks and balls 44. Carrots, whole peeled 45. Carrots, diced 46. Carrots, coins 47. Carrots, Julienne 48. Carrots, shredded 49. Carrots, ground 50. Carrots, sticks 51. Cauliflower, flower 52. Celery, diced 53. Celery, sliced 54. Celery, sticks 55. Cucumber sliced 56. Green Onions, chopped 57. Lettuce, shredded in various screen sizes 58. Onions, diced 59. Onions, sliced 60. Onions, slivered 61. Onions, whole peeled 62. Onions, peeled sliced 63. Red Onions, diced 64. Red Onions, sliced 65. Red Onions, slivered 66. Red Onions, whole peeled 67. Peppers, rings 68. Peppers, Julienne 69. Peppers, diced 70. Peppers slivered 71. Yellow Peppers, Julienne 72. Red Peppers, diced 73. Pineapple chunks 74. Honey Dew, chunks 75. Honey Dew, balls 76. Potatoes, diced 77. Potatoes, diced w/skin 78. Potatoes, russet w/skin 79. Potatoes, whole peeled 80. Potatoes, whole peeled russet 81. Radish, sliced 82. Radish, cleaned 83. Radish, rose 84. Denny Slaw 85. Snow Peas 86. Cabbage, shredded 87. Cabbage, fine chopped 88. Churchs Slaw 89. Yellow Squash, coins 90. Yellow Squash, Julienne 91. Yellow Squash, diced 92. Tomatoes, diced 93. Tomatoes, sliced 94. Watermelon, chunks 95. Watermelon, balls 96. Mixed Melons 97. Stew Veggies 98. C & T Green Beans 99. Zucchini, coins 100. Zucchini, Julienne 101. Zucchini, diced 102. Vegetable Medley 103. Shredded Ginger 104. Hyatt Stir Fry 105. PFD Stir Fry 106. Stir Fry 107. Soup Mix 108. Gazpacho Spaghetti 109. Peas and Cauliflower Salad 110. Au Gratin Potato Salad 111. American Potato Salad 112. Green Bean Salad CODES Lot numbers/pull dates 1025 through 1208 (October 25 through December 8). MANUFACTURER Schuh Catering, Inc., St. Louis, Missouri. RECALLED BY Manufacturer, by telephone November 3, 1994, followed by letter November 4, 1994. Firm-initiated recall complete. DISTRIBUTION Missouri, Illinois. QUANTITY Approximately 96,000 pounds of salads and 192,000 pounds of cut vegetables were distributed between 9/20/94 and 11/3/94. REASON The products (Old Fashioned Potato Salad, Mayonnaise Potato Salad and Mustard Potato Salad) are contaminated with Listeria monocytogenes and the other products may be contaminated with this pathogenic organism. _______________ PRODUCT Various potato salads, in 5 pound and 2 pound containers, under the I & K distributors label: (a) Yoder's Mustard Potato Salad (b) Yoder's American Potato Salad (c) Yoder's Potato Salad (d) Yoder's Redskin Potato Salad (e) Yoder's Amish Potato Salad (f) Yoder's Deluxe Potato Salad (g) Butterfield's Regular Potato Salad (h) Butterfield's Mustard Potato Salad (i) Star Mustard Potato Salad (j) Meijers Deli To-Go Potato Salad. Recall #F-311/320-5. CODE All lots.MANUFACTURER I & K Distributors, Inc., Delphos, Ohio. RECALLED BY Manufacturer, by press release October 21, 1994, followed by telephone and visit, and by notice issued October 24, 1994. Firm-initiated recall complete. DISTRIBUTION Ohio, West Virginia, Indiana, Michigan, Kentucky, Illinois, Missouri, North Carolina, South Carolina, Pennsylvania. QUANTITY As of November 3, 1994, firm estimated none of the suspect salads remained on the market. REASON Product is contaminated with Listeria monocytogenes. _______________ PRODUCT Prepared Foods, Inc. Potatoes sold as peeled, raw potatoes, in 25 pound plastic bags as follows: (a) Whole Peeled Diced Potatoes (b) Whole Peeled Quartered Potatoes (c) Whole Peeled #1 B Sized Potatoes. Recall #F-308/310-5. CODE All lots. MANUFACTURER Prepared Foods, Inc., Detroit, Michigan. RECALLED BY Manufacturer, by telephone October 19, 1994. Firm-initiated recall complete. DISTRIBUTION Michigan, Arizona, Canada. QUANTITY (a) 275 pounds;(b) 650 pounds;(c) 275 pounds were distributed. REASON The products are labeled to contain a "trace" of sodium bisulfite and actually contain sulfites at a level which could lead to a life-threatening anaphylactic reaction, if the products were consumed by an individual exquisitely sensitive to sulfites. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I================ _______________ PRODUCT Pimento Cheese Sandwiches on white bread, in semi-rigid plastic trays with cello overwrap, 4.5 ounces. Recall #F-194-5. CODE All sandwiches manufactured before 11/30/94. MANUFACTURER RDI, Inc., Roanoke, Virginia. RECALLED BY Manufacturer, by visit on or about November 29, 1994. Firm- initiated recall complete. DISTRIBUTION Virginia. QUANTITY 325 sandwiches were distributed; firm estimated that less than 20 percent of product remained on the market at time of recall initiation. REASON Product contained undeclared FD&C Yellow No. 5. _______________ PRODUCT Green Island Farms Stems and Pieces Mushrooms, drained weight 4 ounces. Recall #F-195-5. CODE All lots. The product has an "S1" in the top line of each of the can codes and 94007 or 940109 in the middle lines of the codes. MANUFACTURER Nanning Canned Food Factory, Guangxi, Peoples Republic of China. RECALLED BY Coborn's Inc., St. Cloud, Minnesota, by letter September 8, 1994. Firm-initiated recall complete. DISTRIBUTION Minnesota, Iowa, North Dakota. QUANTITY Approximately 4,000 cases (24 cans per case) were distributed. REASON Product is contaminated with staphylococcal enterotoxin. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II============ _______________ UPDATE Recall #F-191-5, Haggen brand Nut Bread, which appeared in the January 25, 1995 Enforcement Report should read: REASON: Product contains undeclared sesame seeds. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III========== _______________ PRODUCT Pseudoephedrine 60 mg/guaifenesin (Maxifed-G), 500 mg tablets, Rx decongestant, in bottles of 100. Recall #D-053-5. CODE Lot #940335 C MANUFACTURER Mikart, Inc., Atlanta, Georgia. RECALLED BY American Pharmaceuticals, Birmingham, Alabama, by letter November 2, 1994. Firm-initiated recall complete. DISTRIBUTION Georgia, Alabama, Tennessee, Louisiana, Pennsylvania, North Carolina, Mississippi, Virginia, South Carolina, Florida, Illinois. QUANTITY 2,488 bottles were distributed. REASON A bottle was found to contain a foreign tablet (Pyrazinamide 500 mg). _______________ PRODUCT Isocom Capsules, Rx, used for the treatment for relief of vascular and tension headaches, in bottles of 50, 100, and 250. Recall #D-054-5. CODE Lot numbers: U074, U075, V077, V079, W081, X083, X084, X085, A087, A089, B090, C091, C092, C094, D095, E098, E099, F101, F103, F106, G108, H110, H111, H112, H113, I114. EXP dates between 9/94 and 9/95. MANUFACTURER Nutripharm Laboratories, Inc., Flemington, New Jersey. RECALLED BY Manufacturer, by letter on or about August 31, 1994. Firm- initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Firm estimates few bottles remain on market. REASON Insufficient stability data to support expiration date. _______________ PRODUCT Century Pharmaceuticals brand Potassium Chloride 20% Solution in pint bottles, Rx source of potassium. Recall #D-055-5. CODE Lot #6767 EXP 9/95. MANUFACTURER Century Pharmaceuticals, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter January 14, 1994. Firm-initiated recall complete. DISTRIBUTION Maryland, Mississippi, Arizona, South Dakota, Nebraska, Minnesota, Wyoming, New Mexico. QUANTITY 932 pints were distributed. REASON Presence of mold in product. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II====== _______________ PRODUCT All products distributed from units collected between March 23, 1994, and March 27, 1994. Recall #B-152-5.CODE Contact FDA, Center for Biologics Evaluation and Research, Recalls and Administrative Actions Branch (301) 827-6220* for unit numbers collected between March 23, 1994, and March 27, 1994. MANUFACTURER The American National Red Cross, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone March 29, 1994, followed by letter March 29, 1994. Firm-initiated recall complete. DISTRIBUTION Undetermined. QUANTITY Undetermined. REASON Blood products, incorrectly tested for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), were distributed ._______________ PRODUCT Red Blood Cells, Leukocytes Removed. Recall #B-153-5. CODE Unit numbers: 15043-3398, 15043-5421. MANUFACTURER United Blood Services Blood Systems, Inc., Lubbock, Texas. RECALLED BY Manufacturer, by telephone and by letter dated February 2, 1994. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 2 units. REASON Blood products, in which filtration and the addition of additive solution occurred more than eight hours after collection, was distributed. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II=========== _______________ PRODUCT Motorized Three-Wheeled Vehicle, a battery powered device intended for medical purposes that is used for outside transportation by disabled persons: (a) Legend Model #SC300; (b) Sunrunner Model SC400. Recall #Z-145/146-5. CODE Serial numbers: (a) L-20001, L-20101, L-20102, L-20104, L-20105, L-20107 through L-20121, L-20123 through L-20125, L-20127 through L-20130, L-20132 through L-20135; L-20138, L-20140, L-20141, L-20143 through L-20148, L-20150 through L-20154, L-20161 through L-20167, L-20169, L-20170; (b) S-20122, S-20136, S-60001 through S-60010. MANUFACTURER Pride Health Care, Inc., West Wyoming, Pennsylvania. RECALLED BY Manufacturer, by letter on or about April 5, 1993. Firm- initiated field correction complete. DISTRIBUTION Arkansas, California, Colorado, Florida, Connecticut, Illinois, Iowa, Minnesota, New York, North Carolina, Nebraska, Ohio, Pennsylvania, Texas, Wisconsin, Louisiana, Kentucky, Washington State, Oregon, Canada. QUANTITY Firm estimates there are no uncorrected scooters in commerce. REASON The base of the seat component of the device was not welded properly, which could cause the seat component to break off the device. _______________ PRODUCT Stryker Thermaltek 300 Portable Patient Warmer. Recall #Z-314-5. CODE All models. MANUFACTURER Stryker Patient Handling, Kalamazoo, Michigan. RECALLED BY Manufacturer, by letter sent September 27 and 28, 1994. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 293 units were distributed. REASON When the warming device is set on "High", the device does not automatically cool down after a period of time, resulting in patient burns. _______________ PRODUCT Vector MTI Ambulatory Infusion Pumps: (a) Model 102040; (b) Model 102045. Recall #Z-331/332-5. CODE Pump Models 102040 and 102045 with Software Version Rev. 156 and earlier. MANUFACTURER Infusion Technology, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer, by telephone November 7, 1994. Firm-initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY 88 units were distributed. REASON When the infusion pump is set to the Total Parenteral Nutrition mode, the pump allows the potential for an incorrect infusion rate, but will not over-infuse. The lower infusion rate may result in hypoglycemia. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II======== _______________ PRODUCT C-Taper Head/Modular Femoral Bearing Head: (a) 26 mm, Catalog #06-2605; (b) 28 mm, Catalog #06-2805. Recall #Z-147/148-5. CODE Case codes: (a) 11367505; (b) 11374702. MANUFACTURER Osteonics, Inc., Allendale, New Jersey. RECALLED BY Manufacturer, by telephone March 1, 1994, followed by letter March 9, 1994. Firm-initiated recall complete. DISTRIBUTION Nationwide and Japan. QUANTITY 80 units were distributed. REASON Packaging mix-up -- The 26 mm labeled package may contain the 28 mm unit, or vice versa. _______________ PRODUCT Aldetect Formaldehyde Test Reagent for in-vitro diagnostic use, product is sold as 0.2 ml liquid in 2 ml ampule, 400 ampules per case. Recall #Z-300-5. CODE Lot numbers: 5240, 5241, 5242, 5243, 5245, 5247. MANUFACTURER Pochemco, Inc., Chicopee, Massachusetts. RECALLED BY DeWallace Technical Sales, Inc., Worcester, Massachusetts, by telephone June 13, 1994, and by letter November 3, 1994. Firm-initiated recall ongoing.DISTRIBUTION Nationwide. QUANTITY 44 cases of lot 5240, 46 case of lot 5241, 45 cases of 5242 were distributed; firm estimates none of these lots remain on the market. 18 cases of lot 5243, 41 cases of lot 5245, and 44 cases of lot 5247 were distributed. REASON Product exhibits discoloration. It is unstable, and may result in false positives which may cause the user to incorrectly conclude that formaldehyde is present in dialysate solutions. _______________ PRODUCT Abbott Vision Glycated Hb Calibrator Kit, used for calibrating the Abbott Vision Glycated HB Test on the Abbott Vision System to generate a calibration curve used to determine the percent hemoglobin A1C in a specimen. Recall #Z-305-5. CODE Calibrator lot 83706A400. MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone May 9-13, 1994, followed by letter May 23, 1994. Firm-initiated recall complete. DISTRIBUTION Nationwide, Canada, Brazil, Italy, Japan, Singapore, Taiwan, Australia, Germany. QUANTITY 2,567 sets were distributed. REASON This lot of the calibrator kit had a higher value than assigned. _______________ PRODUCT Blood Agar (TSA with Sheep Blood), an in-vitro diagnostic plated media used as a general purpose medium for the growth of a wide variety of microorganisms. Recall #Z-306-5. CODE Catalog #01-202. Lot #2042, including Segment #123 EXP 7/28/94. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by letter June 13, 1994. Firm-initiated recall complete. DISTRIBUTION Florida, Nebraska, Missouri, Texas, Illinois, Wisconsin, Michigan, Minnesota, Alabama, South Carolina, Georgia, North Carolina, Indiana, Ohio, Pennsylvania, Oklahoma, Iowa. QUANTITY Firm estimated that none of lot 2042 remained on the market. However, only 1,100 of the 1,600 plates from Segment 123 were confirmed to be recovered at time of recall initiation. REASON The plates had bacterial contamination. _______________ PRODUCT Phenol Red Broth with 1% Sorbitol, an in-vitro diagnostic recommended for use in qualitative procedures for the determination of fermentation reactions of micoroganisms. Recall #Z-307-5 CODE Catalog #06-2412. Lot #4511 EXP 11/30/94. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by telephone on or about June 9, 1994. Firm- initiated recall complete. DISTRIBUTION Wisconsin, California, Texas, Georgia, Ohio, Connecticut, Missouri, New York, Virginia. QUANTITY 640 tubes were distributed; firm estimates none remains on the market. - REASON The box labeled as Phenol Red Broth w 1% Sorbitol contained the product CTA Dextrose. _______________ PRODUCT Bordetella Pertussis ATCC 9340 Bacti Disk, an in-vitro diagnostic product recommended for use in laboratory quality assurance procedures. Recall #Z-308-5. CODE Catalog #19-008. Lot #3931. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by telephone April 1, 1994. Firm-initiated recall complete. DISTRIBUTION Iowa, Florida, California, Ohio, Indiana, Michigan, New York, Illinois, Arkansas, Maryland, Kansas. QUANTITY 17 vials were distributed; firm estimates none remains on the market. REASON The Bacti Disk labeled as Bordetella Pertussis ATC 9340 actually contained the organism Bordetella Parapertussis. _______________ PRODUCT Penile implants: (a) Ultrex Plus 18 cm Infrapubic Implant, Part #72401467; (b) Ultrex Plus 18 cm Penile Scrotal Implant, Part #72401466. Recall #Z-312/313-5. CODE Lot numbers: (a) AJ767; (b) AJ766. MANUFACTURER American Medical Systems, Inc., Minnetonka, Minnesota. RECALLED BY Manufacturer, by telephone October 5 and 7, 1994. Firm- initiated recall complete. DISTRIBUTION Texas, North Carolina, California. QUANTITY Firm reported that as of 11/17/94 8 of the 10 Penile Scrotal implants (the other two had been implanted) and 9 of 9 Infrapubic implants had been returned to AMS. REASON The tubing between the cylinders and the pump is too short in Lot AJ767 and too long in lot AJ766. _______________ PRODUCT Ultracast Non-Convertible Buccal Tubes, used with dental braces to translate torque and rotational forces from the band to the teeth: (a) Maxillary Double Tube with Mesial Hook, Catalog numbers 003-291CR, 003-291CL, 003-293CR, 003- 293CL; (b) Mandibular Double Tube with Ball Hook, Catalog numbers 004-213CR, 004-213CL, 004-214CR, 004-214CL. Recall #Z-317/318-5. CODE No codes or lot numbers on packages. Units sold prior to March 1993 are affected.MANUFACTURER American Orthodontics Corporation, Sheboygan, Wisconsin. RECALLED BY Manufacturer, by telephone during March 1993. Firm- initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Approximately 5,400 tubes were distributed; firm estimates none remains on the market. REASON Tubes are made of stainless steel with a high carbon content which causes them to be brittle. They may fracture and break apart during use. _______________ PRODUCT Abbott Vision CRP (C-Reactive Protein) Reagent, used with the Abbott Vision System for the quantitative determination of C-reactive protein in anticoagulated whole blood, plasma, or serum. Recall #Z-327-5. CODE Lot #92022A400 EXP 4/1/95. MANUFACTURER Abbott Laboratories, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone December 19-20, 1994. Firm- initiated recall complete. DISTRIBUTION Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Michigan, Montana, New York, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas. QUANTITY 1,572 10-packs were distributed. REASON This lot of the Abbott Vision C-Reactive Protein Reagents the Calibrator A has a higher value than assigned. The absorbance for calibrator A in this system may be abnormally high and could result in aberrant patient results. MEDICAL DEVICE SAFETY ALERTS: ========================= _______________ PRODUCT Digiflator Digital Inflation Devices: (a) Mansfield, Product Number 1520, 20 cc, Angioplasty (b) Microvasive, Product Number 5050, 60 cc, Gastrointestinal (c) Microvasive, Product Number 5055, Alimentary Tract Use (d) Microvasive, Product Number 705-108, 20 cc, Urological; (e) Microvasive, Product Number 705-109, 20 cc, Urological, 12/Box; (f) Medi-Tech, Product Number 15-150, 20 cc, Percutaneous Angioplasty; (g) Medi-Tech, Product Number 15-151, 20 cc, Percutaneous Angioplasty. Safety Alert #N-006/012-5. CODE Product numbers are delineated above. MANUFACTURER South East Instruments Medical, Inc., Gainesville, Florida. ALERTED BY Boston Scientific Corporation, Watertown, Massachusetts, by letter December 5, 1994. DISTRIBUTION Nationwide and international. QUANTITY Firm estimated that 2,386 units remain on market. REASON Loss of electronic display and accuracy of pressure display. END OF ENFORCEMENT REPORT FOR FEBRUARY 1, 1995. ####