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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.
####