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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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