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U.S. Department of Health and Human Services

Class 2 Device Recall Seprafilm

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  Class 2 Device Recall Seprafilm see related information
Date Initiated by Firm April 10, 2008
Date Posted August 24, 2008
Recall Status1 Terminated 3 on September 29, 2015
Recall Number Z-1648-2008
Recall Event ID 47758
PMA Number P950034 
Product Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only
Product Number: 4301-05
Code Information Lot number: 07NP181 Exp June 2010
Recalling Firm/
Genzyme Corporation
45, 51-80 New York Ave and
One Mountain Rd.
Framingham MA 01701
For Additional Information Contact
Manufacturer Reason
for Recall
Sterility may be compromised
FDA Determined
Cause 2
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

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.