Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier).
FDA device recall Z-1648-2008 · posted 2008-08-24 · Terminated
Recall details
- Recalling firm
- Genzyme Corporation
- Reason for recall
- Sterility may be compromised
- Action taken
- Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.
- Root cause
- Employee error
- Status
- Terminated
- Quantity affected
- 517 (10 packs)
- Distribution
- Nationwide Korea, Taiwan, Japan
- Date initiated
- 2008-04-10
- Date posted
- 2008-08-24
- Date terminated
- 2015-09-29
- Location
- Framingham, MA
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