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U.S. Department of Health and Human Services

Medical Devices

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Gelfoam Sterile Power and Sponge

Class I Recall
Date Recall Initiated:
November 17, 2000
Product:
Gelfoam Sterile Power and Sponge
Use:
For application to bleeding surfaces to slow and stop the flow of blood. This product is used by physicians during surgical procedures to control bleeding when applying pressure or tying-off blood vessels is ineffective or impractical. It is not a consumer product.
Recalling Firm:
Pharmacia Corporation
7000 Portage Road
Kalamazoo, MI 49001
Reason for Recall:
Metal (aluminum) shavings were found inside bottles of the product. This occurred due to a design fault of the lid where the removal or resealing of the product caused the shavings of aluminum to fall into the bottle's contents.
Public Contact:
Mr. John Nadelin
Senior Manager for Corporate Quality Assurance
Phone: 1-800-293-0088
FDA District:
Detroit, Michigan
FDA Comment:
FDA considers there to be a risk of local fibrosis (thickening or scarring of the tissue) and infection from the use of this product.