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FDA > CDRH > Medical Device Recalls > Class I Recall - Absorbable Hemostatic Agent

Medical Device Recalls
Class I Recall - Absorbable Hemostatic Agent

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.

For additional information on this product recall, see the FDA Enforcement Report located at:
http://www.fda.gov/bbs/topics/Enforce/2001/ENF00679.html. Scroll down to "Recalls and Field Corrections: Device - Class 1".

Updated November 5, 2001

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