| Class 2 Device Recall Genzyme | |
Date Initiated by Firm | June 13, 2012 |
Date Posted | June 21, 2012 |
Recall Status1 |
Terminated 3 on July 24, 2013 |
Recall Number | Z-1856-2012 |
Recall Event ID |
62127 |
PMA Number | P950034 |
Product Classification |
Barrier, absorable, adhesion - Product Code MCN
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Product | seprafilm Single Site ADHESION BARRIER
Re-order Number: 6641-01
Product Usage:
Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder. |
Code Information |
Lot number: 11NP685 . Exp 2014- 11 |
Recalling Firm/ Manufacturer |
Genzyme Corporation 31,45,49,51,55,74,76, & 80 New York Ave. Framingham MA 01702-5733
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For Additional Information Contact | 508-872-8400 |
Manufacturer Reason for Recall | Sterility of product may be compromised due to packaging defect |
FDA Determined Cause 2 | Packaging process control |
Action | Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069. |
Quantity in Commerce | 1285 units |
Distribution | Worldwide Distribution - US (nationwide) and the country of S. Korea |
Total Product Life Cycle | TPLC Device Report |
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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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PMA Database | PMAs with Product Code = MCN
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