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
01/02/1991
FDA Enforcement for the week of January 3, 1991
FDA ENFORCEMENT REPORT
FOR JANUARY 2, 1991
January 2, 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.
Product: (a) Broadway brand Soft Egg Bagels, packed six bagels
per 16 ounce plastic bags; (b) New York Bagel Boys brand
Sliced Egg Bagels packed 6 bagels per 16 ounce green
plastic bag. Recall #F-038/039-1.
Code: (a) 12 NOV; (b) None
Manufacturer: General Bagel, Inc., Bothell, Washington.
-1-
Recalled by: Manufacturer, by telephone November 6, 1990.
Firm-initiated recall ongoing.
Distribution: Washington state, Oregon, Idaho.
Quantity: Approximately (a) 362 bags; (b) 276 bags were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
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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
Class I -
NONE
Class II -
Product: (a) Red Blood Cells. Recall #B-051-1.
Code: Unit 4254381.
Manufacturer: United States Naval Hospital, Long Beach, California.
Recalled by: Manufacturer, by telephone September 28, 1989.
Firm-initiated recall complete.
Distribution: California.
Quantity: 1 unit.
Reason: Red Blood Cells which tested repeatably reactive for
the hepatitis B surface antigen (HBsAg) were distributed.
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Product: (a) Red Blood Cells; (b) Platelets. Recall #B-053/054-1.
Code: Unit #14F30735.
Manufacturer: American Red Cross, Yakima, Washington.
Recalled by: Manufacturer, by telephone June 11, 1990. Firm-initiated
recall complete.
Distribution: Washington state.
Quantity: 1 unit of each component.
Reason: Blood components of donor reporting an occupational
exposure to blood from a patient with hepatitis B, were
distributed.
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-2-
Product: (a) Red Blood Cells; (b) Recovered Plasma, Pooled.
Recall #B-057/058-1.
Code: Unit numbers: (a) 1282884, 1285836, 1287075;
(b) Pool numbers: 23695 (includes Recovered Plasma
unit 1282884), 24193 (includes Recovered Plasma, unit
1285836) and 24405 (includes Recovered Plasma, unit
1287075.
Manufacturer: Mississippi Blood Services, Inc., Jackson, Mississippi.
Recalled by: Manufacturer, by telephone on or about September 19, 1989.
Firm-initiated recall ongoing.
Distribution: Mississippi, California.
Quantity: 3 units of each component.
Reason: Units of blood drawn from donors who indicated they
are in a high risk group for AIDS were distributed.
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Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-073/074-1.
Code: Unit #8905019.
Manufacturer: Greater Metropolitan Community Blood Services, Inc.,
New York, New York.
Recalled by: Manufacturer, by telephone September 19, 1990.
Firm-initiated recall complete.
Distribution: New York.
Quantity: 1 unit of each component.
Reason: Blood products repeatably reactive for the hepatitis
B surface antigen (HBsAg) were distributed.
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Class III -
Product: Red Blood Cells. Recall #B-052-1.
Code: Unit #425380.
Manufacturer: United States Naval Hospital, Long Beach, California.
Recalled by: Manufacturer, by telephone September 28, 1990. Firm-
initiated recall complete.
Distribution: California.
Quantity: 1 unit was distributed.
Reason: Red Blood Cells which tested repeatably reactive for
the hepatitis B surface antigen (HBsAg) were distributed.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
-3-
Class II -
Product: AOA Halo System For MR Imaging, designed to immobilize
and stabilize the cervical spine. It is manufactured
predominately of non-ferfomagnetic; non conductive
materials, allowing patients to be imaged with
conventional x-ray, CAT scan or the magnetic
resonance imaging. The product is labeled with the
Kirschner label: a) Halo Vest Synthetic Liner;
(b) Halo Vest w/sheepskin liner;
(c) Halo Vest w/Hinged Connector. Recall #Z-144/146-1.
Code: (a) 750102 Halo Vest w/synthetic liner, hinged connector
assembly 23"-26"
750103 Halo Vest w/synthetic liner, hinged connector
assembly 27"-30"
750104 Halo Vest w/synthetic liner, hinged connector
assembly 31"-34"
750105 Halo Vest w/synthetic liner, hinged connector
assembly 35"-38"
750106 Halo Vest w/synthetic liner, hinged connector
assembly 39"-42"
750107 Halo Vest w/synthetic liner, hinged connector
assembly 43"-46"
750108 Halo Vest w/synthetic liner, hinged connector
assembly 47"-50"
(b) 750112 Halo Vest w/Sheepskin Liner, hinged connector
assembly 23"-26"
750113 Halo Vest w/Sheepskin Liner, hinged connector
assembly 27"-30"
750114 Halo Vest w/Sheepskin Liner, hinged connector
assembly 31"-34"
750115 Halo Vest w/Sheepskin Liner, hinged connector
assembly 35"-38"
750116 Halo Vest w/Sheepskin Liner, hinged connector
assembly 39"-42"
750117 Halo Vest w/Sheepskin Liner, hinged connector
assembly 43"-46"
750118 Halo Vest w/Sheepskin Liner, hinged connector
assembly 27"-50"
(c) 751002 Halo Vest MR w/hinged connector assembly
23"-26"
751003 Halo Vest MR w/hinged connector assembly 27"-30"
751004 Halo Vest MR w/hinged connector assembly 31"-34"
751005 Halo Vest MR w/hinged connector assembly 35"-38"
751006 Halo Vest MR w/hinged connector assembly 39"-42"
751007 Halo Vest MR w/hinged connector assembly 43"-46"
751008 Halo Vest MR w/hinged connector assembly 47"-50"
Manufacturer: All Orthopedic Appliances (AOA), (Division of Kirschner
Medical Corp.), Marlow, Oklahoma.
Recalled by: Kirschner Medical Corporation, Timonium, Maryland, by
letter September 22, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Switzerland.
-4-
Quantity: 76 units were distributed.
Reason: Cracks may develop in the rod pivot bracket, on both
sides, front and back of the vest resulting from over
tightening during device installation.
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Class III -
Product: SeeQuence (polymacon) Contact Lens, (a) -3.25 diopter;
(b) -6.5 diopter, packed 13 lenses per carton.
Recall #Z-147/148-1.
Code: (a) R007444; (b) R007744.
Manufacturer: Bausch & Lomb, Inc., Rochester, New York.
Recalled by: Manufacturer, by telephone October 11, 1990.
Firm-initiated recall complete.
Distribution: Nationwide and international.
Quantity: (a) 53 cartons; (b) 53 cartons were distributed.
Reason: Mislabeling - Lens cartons are labeled -3.25D,
lot #R00744 actually contains individual lens packages
labeled and containing -6.50D lenses, lot R007744.
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Product: IMx Reaction Cells, 100 cells per box accessory item used
with all of the Microparticle Enzyme Immunoassay (MEIA)
tests of the IMx System. Recall #Z-168-1.
Code: Lot #43799M200 EXP 16SEP91.
Manufacturer: Abbott Laboratories, North Chicago, Illinois.
Recalled by: Manufacturer, by telephone between October 30 and 29,
1990 followed by letter October 24, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 5,741 boxes were distributed; firm estimates none remains
on the market.
Reason: Defective matrixes may cause erroneous assay results.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Levamisole Phosphate, Injectable Solution, OTC veterinary
antihelmintic under the following labels:
Tramisol, 13.65% concentration, in 100 ml. vials marketed
by American Cyanamid Co.; Ripercol, injectable, 13.65%
concentration, in 100 ml vials, marketed by Cyanamid
Canada Inc.; Levasole, injectable, 13.65 concentration, in
100 ml vials, marketed by Pitman-Moore. Recall #V-052-1.
-5-
Code: Lot #681-535-007.
Manufacturer: Cyanamid Agriculture de Puerto Rico, Inc., Manati,
Puerto Rico.
Recalled by: American Cyanamid Company, Wayne, New Jersey, by letters
dated October 15 and 17, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide, Puerto Rico, Canada.
Quantity: 19,670 units were distributed; firm estimates 12,981
units were distributed.
Reason: Sticky precipitate in vials of the product.
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Class III -
NONE