Recall of Laparotomy Sponges -- United States, 1993
On September 8, 1993, Medical Action Industries, Inc. * (MAI)
(Farmingdale, New York), announced a voluntary recall of all 300
and 400 Series laparotomy sponges packaged as sterile (lot numbers
100-1434) because of fungal contamination of the sponges. No human
disease has been reported related to use of these sponges, which
are used in surgical procedures to retract organs or absorb blood
and/or other fluids. Cultures performed by the Food and Drug
Administration (FDA) and independent laboratories have been
positive for Pyronema domesticum and a nonsporulating
bascidiomycete. Additional testing by FDA of sponges manufactured
by this and other firms is under way.
Health-care facilities should inspect their inventory of
laparotomy sponges, discontinue use of sponges from the affected
lots, and return unused sponges to the manufacturer. Sponges
subject to the recall should not be resterilized or reprocessed for
use. Alternative manufacturers or distributors may be contacted in
case of shortages.
Prophylactic treatment of patients exposed to the affected
sponges is not recommended, but hospital personnel should maintain
active surveillance for surgical site infections. If postoperative
infection develops, patient cultures should be evaluated for fungal
pathogens.
Any laparotomy sponges, other than those covered by the
recall, that are visibly contaminated, moist, or defectively
packaged should immediately be reported to FDA's MedWatch Reporting
Program, telephone (800) 332-1088. Any human infection suspected to
be related to this contamination should be reported to CDC's
Hospital Infections Program, National Center for Infectious
Diseases, telephone (404) 639-1550.
Reported by: Office of Surveillance and Biometrics, Center for
Devices and Radiological Health, Food and Drug Administration. Div
of Bacterial and Mycotic Diseases and Hospital Infections Program,
National Center for Infectious Diseases, CDC.
Use of trade names and commercial sources is for identification
only and does not imply endorsement by the Public Health Service or
the U.S. Department of Health and Human Services.
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