Class 2 Device Recall Seprafilm

• Date Initiated by Firm: April 10, 2008
• Date Posted: August 24, 2008
• Recall Status: Terminated on September 29, 2015
• Recall Number: Z-1647-2008
• Recall Event ID: 47758
• PMA Number: P950034
• Product: Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
• Code Information: 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
• Recalling Firm/ Manufacturer: Genzyme Corporation; 45, 51-80 New York Ave and; One Mountain Rd.; Framingham MA 01701
• For Additional Information Contact: 508-872-8400
• Manufacturer Reason for Recall: Sterility may be compromised
• FDA Determined 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: 2632 (10 pack)
• Distribution: Nationwide Korea, Taiwan, Japan

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.