FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

September 9, 1998
98-36

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________ PRODUCT
Swallow Brand Dries Sweet Potato. Recall #F-593-8.

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.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________ PRODUCT
Chooz calcium carbonate mint flavored gum, 16 mint gum tablets. Recall #D-233-8.

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.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______ PRODUCT
a)Red Blood Cells, b)Platelets, c)Fresh Frozen Plasma, d)Cryoprecipitated AHF, e) Plasma, f)Recovered Plasma, g) Red Blood Cells, for further manufacturing. Recall #B-1506/ B-1513-8.

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.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______ PRODUCT
Mobile Shower Commode Chair and Wheeled Leg Extensions. Recall # Z-822/823-8.

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.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______ PRODUCT
Colleague Volumetric Infusion Pumps. Recall #Z-798-8.

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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