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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:
 January 19, 2001
Product:
 Adcon-L and Adcon-T/N sterile
Use:
 For use in single-level, posterior, lumbar disk surgeries (laminectomy) where nerve roots are exposed. Used to inhibit post-surgical peridural fibrosis (thickening and scarring of the tissue surrounding the disks of the spine). This device is used by physicians during surgical procedures. It is not a consumer product.
Recalling Firm:
 Gliatech, Inc.
Cleveland, Ohio
Reason for Recall:
 Aluminum particles were seen in jars of Gelfoam (a raw material component recalled on 11/12/00 by its manufacturer, Pharmacia Corporation) used to manufacture Adcon-L. The particles come from the aluminum lid liner of the containers of Gelfoam and fall into the bottle when the lid is opened or resealed.
Public Contact:
 Mr. Terry McMahon
Regulatory Affairs Consultant
Phone: 1-800-943-3200
FDA District:
 Cincinnati, Ohio
FDA Comment:
 FDA considers there to be a risk of post operative infections and post operative pain.

Updated November 5, 2001

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