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
04/03/1990
FDA Enforcement for the week of April 4, 1990
FDA ENFORCEMENT REPORT
FOR APRIL 4, 1990
April 4, 1990
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
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
NONE
-1-
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Recovered Plasma. Recall #B-098-0.
Code: Unit #10955.
Manufacturer: Our Lady of Lourdes Regional Medical Center, Lafayette,
Louisiana.
Recalled by: Manufacturer, by telephone January 19, 1990. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: 1 unit was distributed.
Reason: Recovered Plasma collected from a donor who had previously
tested repeatably reactive for the antibody to the human
immunodeficiency virus (anti-HIV-1) was distributed.
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Product: (a) Modified Whole Blood; (b) Red Blood Cells;
(c) Cryoprecipitated AHF; (d) Fresh Frozen Plasma;
(e) Platelets; (f) Recovered Plasma. Recall #B-099/104-0.
Code: Unit numbers: (a) 5108219;
(b) 1125891, 1130308, 1338407, 1530985, 1536049, 2115156,
2223153, 2605062, 3119461, 3229574, 3238316, 3315824,
3316312, 3402517, 3404084, 5219383, 5312616;
(c) 1125891;
(d) 2115156, 2223153, 3119461, 5312616;
(e) 1130308, 1530985, 1536049, 2115156, 2605062, 3119461,
3404084, 5108219;
(f) 1125891, 1130308, 1338407, 1530985, 1536049, 2605062,
3229574, 3238316, 3315824, 3316312, 3402517, 3404084,
5219383.
Manufacturer: Louisiana Blood Center, Shreveport, Louisiana.
Recalled by: Manufacturer, by letter between December 1988 and
October 1989. Firm-initiated recall ongoing.
Distribution: Louisiana, Texas, Florida.
Quantity: (a) 1 unit; (b) 17 units; (c) 1 unit; (d) 4 units;
(e) 8 units; (f) 13 units were distributed.
Reason: Blood products, drawn from donors who had previously
tested repeatably reactive for the antibody to the
human immunodeficiency virus (anti-HIV-1) or whose test
results were interpreted improperly for anti-HIV-1, were
distributed.
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-2-
Class III -
Product: (a) Whole Blood; (b) Red Blood Cells;
(c) Fresh Frozen Plasma; (d) Platelets; (e) Recovered Plasma.
Recall #B-105/109-0.
Code: Unit numbers: (a) 3123009; (b) 1228231, 1231654, 1426925,
2116171, 3115000, 3118767, 3121203, 3123837, 3225345,
3226225, 3315361, 3402697, 3403741, 3404068;
(c) 1228231, 1426925, 3226225;
(d) 2116171, 3118767, 3123837;
(e) 1231654, 2116171, 3115000, 3118767, 3121203, 3225345,
3315361, 3402697, 3403741, 3404068.
Manufacturer: Louisiana Blood Center, Shreveport, Louisiana.
Recalled by: Manufacturer, by letter betweenDecember 1988 and October
1989. Firm-initiated recall ongoing.
Distribution: Louisiana, Texas, Florida.
Quantity: (a) 1 unit; (b) 14 units; (c) 3 units; (d) 3 units;
(e) 10 units were distributed.
Reason: Blood products, drawn from donors who had previously
tested repeatably reactive for the antibody to the human
immunodeficiency virus (anti-HIV-1), were distributed.
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Product: Red Blood Cells. Recall #B-088-0.
Code: Unit #11N35595.
Manufacturer: American Red Cross, MO-IL Regional Red Cross Blood Services,
St. Louis, Missouri.
Recalled by: Manufacturer, by telephone September 5, 1989. Firm-initiated
recall complete.
Distribution: Illinois.
Quantity: 1 unit was distributed and destroyed.
Reason: A unit of Red Blood Cells, which tested positive for
syphilis by the Rapid Plasma Reagin (RPR) methodology,
was distributed.
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MEDICAL DEVICES AND RADIOLOGY
NOTE: Recall #Z-557/558-9, Validator 8 & 10 Autoclaves, which
appeared in the May 3, 1989 Enforcement Report has been
reclassified. Based on new information submitted by
Pelton & Crane Company, Charlotte, North Carolina, the
classification has been changed from Class II to Class III.
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VETERINARY PRODUCTS
NONE