CODE
None.
MANUFACTURER
Jiangmen Cereals and Oils Import & Export company of Guangdong,
Guangdong, China.
RECALLED BY
Wicsun Trading, Inc., Brooklyn, NY., by press release on April
24, 1998. Firm initiated recall complete.
DISTRIBUTION
New York, Pennsylviana, Massachuttes.
QUANTITY 9.5 cartons (45 X 340 gram packages) and 2 cartons 100 X 6 oz. packages.
REASON This products contains undeclared sulfites.
________
PRODUCT
Fresh Rock Shrimp. Recall #F-595-8.
CODE
No lot or code numbers.
MANUFACTURER
Fernandina Seafood Co., Fernandina Beach, FL.
RECALLED BY
Manufacturer, by fax on July 22, 1998. Firm-initiated recall
on-going.
DISTRIBUTION
Nationwide.
QUANTITY 3,791/8lb tubs.
REASON The product contains undeclared sulfites.
_______
PRODUCT
Tennessee Pride Family Pack (12 per carton) Sausage and Biscuit,
Net Weight 19.2 ozs. Recall #F-596-8.
CODE
0157 8DA. UPC 72290 00096.
MANUFACTURER
Manufacturer (Finished Sandwiches): Tennessee Quality Foods, Dickson, TN Manufacturer (Pre-Cooked Sausage): Odom's Sausage, Little Rock, AR Recalling Firm: Odom's Tennessee Pride, Madison, TN.
RECALLED BY
Odom's Tennessee Pride, Madison, TN., by telephone on August 3,
1998 and by press release on August 4, 1998. Firm-initiated
recall on-going.
DISTRIBUTION
Illinois, Ohio and Florida.
QUANTITY 160 cases.
REASON The product is cantaminated with Listeria monocytogenes.
_______
PRODUCT
A)Golden Raisins, b)Berry Nutty Trail Mix.
Recall #F-597/598-8.
CODE
No code.
MANUFACTURER
Aurora Products, Inc., Bridgeport, Ct.
RECALLED BY
Manufacturer, by press releases, dated July 29, 1998 and August
3, 1998. Firm-initiated recall complete.
DISTRIBUTION
New York and Conneticut.
QUANTITY a)approx. 17 cases b)approx. 36 cases.
REASON The product contains undeclaired sulfites.
_______
PRODUCT
F-599-8 Tuna Salad F-600-8 Tuna Salad Special F-601-8 Turkey & Cheese Triple Cut F-602-8 Ham & Cheese Triple Cut F-603-8 Beef & Cheese Triple Cut F-604-8 Club Triple Cut F-605-8 Italian Meatball Sandwich F-606-8 Sausage & Cheese English Muffin F-607-8 Double Cheeseburger F-608-8 Bagel with Cream Cheese F-609-8 Bagel & Turkey with Cream Cheese F-610-8 Bagel & Ham with Cream Cheese F-611-8 Roast Beef Vienna F-612-8 Turkey & Cheese Vienna F-613-8 Ham & Cheese Vienna F-614-8 Combo Vienna F-615-8 British F-616-8 Breaded Chicken Sandwich.
CODE
Product marked with pull dates prior to 8/14/98.
MANUFACTURER
Totem Food Products, Inc., Kent, Washington.
RECALLED BY
Manufacturer, by telephone and press release on July 31, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Washington state.
QUANTITY 600 sandwiches.
REASON Products contain undeclared egg and/or egg yolk, and/or wheat.
CODE
Lot Nos. 8LDL1000, 8LD1002, 8LDL1003, 8LDL1004, 8LDL1005,
8LDL1006, 8E03GP.
MANUFACTURER
Schering-Plough
HealthCare Products, Inc.
Memphis, Tennessee.
RECALLED BY
Manufacturer, by letter on August 8, 1998. Firm-initiated
recall on-going.
DISTRIBUTION
Nationwide.
QUANTITY 150,000 cartons.
REASON Label does not bear the advisory statement for PKU about the presence of Aspartame in the product.
CODE
Contact FDA, Center for Biologics Evalution and Research, Office
of compliance and biologics Quality (301) 827-6220 for individual
unit numbers recalled.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letters on March 28, 1997 and April 13, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Ohio, California, New York, Florida, Massachusetts and
Switzerland.
QUANTITY a)130 units, b)67 units c)3 units d)2 units e) 20 units f)108 units g)7 units.
REASON Blood products,which tested negative for antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors who previously tested repeatedly reactive for anti-HIV-1 and were improperly reentered, were distributed.
CODE
Serial Nos. 71027 through 80511.
MANUFACTURER
Invacare Corporation, Elyria, Ohio.
RECALLED BY
Manufacturer, by Certified Mail on July 8, 1998. Firm-initiated
recall on-going.
DISTRIBUTION
Nationwide.
QUANTITY 2,568 distributed.
REASON Devices adulterated in that a newly supplied castor wheel is too soft such that the wheel may buckle under load and while turning.
_______
PRODUCT
The product under recall is labeled as the Kaufman
Vitrector III kit, 5 units per box, which contains a Vitreous
Cutter and Remover which is used in ophthalmic surgery for the
simultaneous irrigation and controlled removal of vitreous
material from the eyeball. Recall # Z-827-8.
CODE
Lot Numbers 13228800, 13099300 and 14145800 are under recall.
MANUFACTURER
Xomed Surgical Products, Inc., Jacksonville, FL.
RECALLED BY
Manufacturer, by letter on June 12, 1998. Firm-initiated recall
complete.
DISTRIBUTION
KANAS, California, Missouri, Pennsylviana, Colorado.
They also sold product to the following international
accounts:
ASF Gestion SL Gil Imon No. 6 Local Madrid, Spain Baka Medical CA Av. Stadium con Calle Vargas Los Chaguaramos, Caracas, Venezuela Xomed Australia Sydney, Australia Xomed France 6 Av. de Norvege 91941 Courtaboeuf Cedex, France Xomed UK Ltd. Unit 5 West Point Row, Almondsbury, Bristol B532 4QG United Kingdom.
QUANTITY 400 units.
REASON Cracks were found in the irrigation adaptor resulting in leakage of irrigation fluid during use.
_______
PRODUCT
Reagent Pack. Recall #Z-835-8.
CODE
2A02-60/69. Lot #40354Q100.
MANUFACTURER
Abbott Labortories, Barceloneta, PR.
RECALLED BY
Manufacturer, by letter on July 30, 1998. Firm-initiated recall
on-going.
DISTRIBUTION
Nationwide.
QUANTITY 1,151 kits. Germany, Taiwan, Italy, Bahamas, Japan, Jamaica, Singapore, Chili, Hong Kong, Korea, El Salvador, Canada.
REASON Calibrations curve error.
_______
PRODUCT
a)Starter Kit. Recall #Z-836-8 b)Replacement Cartridge Recall #837-8.
CODE
a)Nos. 985000 and 985015 b)Nos. 985001 and 985080.
MANUFACTURER
Laerdal Medical Corp., Wappingers, NY.
RECALLED BY
Manufacturer, on August 4, 1998, by certified letter. 0
.
Firm-initiated on-going.
DISTRIBUTION
Nationwide. Canada, Austrailia, Norway, Costa Rica and
military.
QUANTITY 13,300 cases.
REASON The intake valve may be partically or totally occuladed possibly causing the suction unit to malfunction.
CODE
2M8151.
MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL.
RECALLED BY
Manufacturer, on July 13, 1998 by letter. Firm-initiated recall
on-going.
DISTRIBUTION
Nationwide.
QUANTITY 4,221 units.
REASON The battery charge level indicator may understate the true battery capacity.
_______
PRODUCT
The recalled item to be corrected in the field is the Instruction
Manual for the EPIX VT Dual Channel Transcutaneous Electrical
Nerve Stimulator (TENS device). Recall # Z-826-8.
CODE
The field correction applies to the TENS devices which were
shipped between April 24, 1998 and August 14, 1998. The
defective manuals were put with the devices at the time of
shipment.
MANUFACTURER
Empi, Inc., St. Paul, MN.
RECALLED BY
Manufacturer, on August 19, 1998 by letter. Firm-initiated
recall on-going.
DISTRIBUTION
Nationwide.
QUANTITY 582 shipped.
REASON The instruction manuals to be corrected in the field lack page 3, which normally has some of the precaution statements and some of the product warnings. Most of the important product warnings are on page 2, which is not missing.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 9, 1998.
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