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.
ENFORCE
06/04/1991
FDA Enforcement for the week of 6/5/91
FDA ENFORCEMENT REPORT
FOR JUNE 5, 1991
June 5, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Product: Corn Beverages, in 12 ounce cans. Recall #F-386-1.
Code: Lot #0054.
Manufacturer: Lau Dania Foods, Inc., Dania, Florida.
-1-
Recalled by: Crescent Food Importers, Inc., Westbury, New York,
by letter December 19, 1990. Firm-initiated recall ongoing.
Distribution: Florida, New York.
Quantity: Not determined.
Reason: The product contains coumarin, a nonpermitted food additive.
----
Product: Cinnamon Snap Cookies, in 15 ounce bags. Recall #F-383-1.
Code: The bags are identified with a pull date from Dec 1 to
May 2. The cookies have a 10-week shelf life.
Manufacturer: Archway Cookies, Inc., Ashland, Ohio, by telephone
February 25, 1991. Firm-initiated recall complete.
Distribution: States east of the Mississippi.
Quantity: 175,336 bags were produced.
Reason: The product contains undeclared eggs.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: 3M (arthroscopic) Sheathed Knives. Recall #Z-685-1.
Code: Catalog #80130 through 80742, lot numbers: SEP90 061,
NOV90 074, NOV90 075.
Manufacturer: Questus Corporation, Marblehead, Massachusetts.
Recalled by: 3M Orthopedic Products Division, St. Paul, Minnesota,
by letter dated January 21, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Denmark, Germany, Italy, Japan, Spain, Sweden,
Switzerland, The United Kingdom.
Quantity: 306 boxes (6 blades per box) were distributed.
-2-
Reason: The firm does not have sufficient test data to assure
sterility of the subject lots.
----
Product: Carbon Dioxide Industrial Laser Systems:
(a) Model No. SP 820;
(b) Model No. RS 820;
(c) Model No. SP 825;
(d) Model No. RS 825;
(e) Model No. SP 840;
(f) Model No. RS 840;
(g) Model No. RS 850;
(h) Model No. RS 8100. Recall #Z-686/693-1.
Code: All serial numbers.
Manufacturer: Rofin-Sinar, Inc., San Jose, California.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan April 16, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 251 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that the shutter may not close completely,
and that the shutter monitor does not turn off the
laser in this situation.
----
Class III -
Product: Miller/Galante Total Knee System Tibial Articular Surface,
a component of an implantable knee prosthesis.
Recall #Z-684-1.
Code: Lot #73848800.
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by telephone March 28, 1991 and by letter
March 28, 1991. Firm-initiated recall ongoing.
Distribution: Minnesota, South Carolina, Arkansas, Texas, Ohio,
Belgium, France.
Quantity: 19 pieces were distributed.
Reason: Product is labeled with an incorrect color-coded sticker.
The codes of the sticker is correct for the device, but
shows a likeness of a patella component.
----
-3-
VETERINARY PRODUCTS
Class I -
Product: Vedco Lactated Ringer's Injection, in 1000 ml bottles.
Recall #V-071-1.
Code: Lot #210110.
Manufacturer: Vedco, Inc., St. Joseph, Missouri (own label distributor).
Recalled by: Wendt Professional Laboratories, Inc., Belle Plaine,
Minnesota, by letter dated April 19, 1991. Firm-
initiated recall ongoing.
Distribution: Major distributors are located in Virginia, Texas,
South Dakota, Pennsylvania and Idaho. Product may have
been distributed to surrounding states.
Quantity: 9,643 bottles were distributed.
Reason: Nonsterility. The product was also found to contain 40
Endotoxin units per ml (EU/ML) using LAL test,
exceeding the FDA guideline of .50 EU/ML.
----
Class II -
NONE
Class III -
NONE
Prosecution Actions Filed:
Against: General Welding Supply Corporation,
Product: Oxygen Gas Cylinders (87-521-677).
Charge: Oxygen valved cylinders were filled with carbon dioxide
and released.
Filed: May 17, 1991 - U.S. District Court for the Eastern
District of New York; Criminal #CR91-502, FDC #65304.