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Terminated

Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05

FDA Recall Z-1648-2008 · Posted 2008-08-24

Recalling FirmGenzyme Corporation
Recall StatusTerminated
Date Initiated2008-04-10
Date Terminated2015-09-29
Product Quantity517 (10 packs)

Reason for Recall

Sterility may be compromised

Firm Action

Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.

Root Cause

Employee error

Distribution Pattern

Nationwide Korea, Taiwan, Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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