Genzyme Corporation
Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05
| Date | Aug 24, 2008 (initiated Apr 10, 2008) |
| Status | Terminated |
| Reason | Sterility may be compromised |
| Root cause | Employee error |
| Action | Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product. |
| Quantity | 517 (10 packs) |
| Distribution | Nationwide Korea, Taiwan, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.