Seprafilm Adhesion Barrier (chemically modified sodium… recallZ-1647-2008 · Genzyme Corporation · initiated Apr 10, 2008
Terminated All recalls posted in August 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Genzyme Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility may be compromised
FDA root cause category: Employee error
What the company is doing
Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.
Recall details
- Recall number
- Z-1647-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 10, 2008
- Posted by the FDA
- Aug 24, 2008
- Recalling firm
- Genzyme Corporation
- Quantity
- 2632 (10 pack)
- FDA submissions
- P950034
- Distribution
- Nationwide Korea, Taiwan, Japan
Product description
Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under P950034 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SEPRAFILM 430102Baxter Healthcare Corporation · Barrier, absorbable, adhesion1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 47758).
- Z-1648-2008 · TerminatedSeprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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