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U.S. Department of Health and Human Services

Class 2 Device Recall Genzyme

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  Class 2 Device Recall Genzyme see related information
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
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
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
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.
PMA Database PMAs with Product Code = MCN and Original Applicant = Baxter Healthcare Corporation
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