FDA Recall
Terminated
Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
Recall: Z-1647-2008
·
Initiated April 10, 2008
Recall
- Recall Number
- Z-1647-2008
- Event Number
- 47758
- Firm
- Genzyme Corporation
- FEI Number
- 1220423
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- April 10, 2008
- Posted
- August 24, 2008
- Terminated
- September 29, 2015
- Address
- 45, 51-80 New York Ave, and, Framingham, MA, 01701
Description
Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
Reason
Sterility may be compromised
Action
Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.
Distribution
Nationwide Korea, Taiwan, Japan
Quantity
2632 (10 pack)