Z-1648-2008

Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion...

Name: Z-1648-2008 Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion...
Creator: Genzyme Corporation
Published: 2008-04-10
License: https://open.fda.gov/license/

Genzyme Corporation / initiated 2008-04-10 / Terminated / root cause: manufacturing process

FDA source

Genzyme Corporation began a recall of Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number... on 2008-04-10. The reason FDA records is "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1648-2008
Status: Terminated
Initiated: 2008-04-10
Posted: 2008-08-24
Terminated: 2015-09-29
Recalling firm: Genzyme Corporation
Product: Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05
Reason for recall: Sterility may be compromised
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.
Quantity in commerce: 517 (10 packs)
Distribution: Nationwide Korea, Taiwan, Japan
Product codes and lots: Lot number: 07NP181 Exp June 2010

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)