FDA Medical Device Recalls (openFDA)
Genzyme Corporation: Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
- Recall number
- Z-1647-2008
- Recalling firm
- Genzyme Corporation
- Product
- Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
- Status
- Terminated
- Initiated
- 2008-04-10
- Posted
- 2008-08-24
- Terminated
- 2015-09-29
- 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
- 2632 (10 pack)
- Distribution
- Nationwide Korea, Taiwan, Japan
- Lot, serial or model codes
- Lot Numbers: 07NP135 Exp Date: April 2010; 07NP177 Exp Date: May 2010; 07NP199 Exp Date: June 2010; 07NP216 Exp. Date: July 2010; 07NP311 Exp. Date: May 2010
- 510(k) numbers
- not on file
- PMA numbers
- ["P950034"]
- Product code
- not on file
- Firm FEI
- 1220423
- Firm city
- Framingham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28