Date Initiated by Firm |
April 10, 2008 |
Date Posted |
August 24, 2008 |
Recall Status1 |
Terminated 3 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
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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 |
2632 (10 pack) |
Distribution |
Nationwide
Korea, Taiwan, Japan |
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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.
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