Recall Z-1856-2012 ยท MCN Barrier, Absorbable, Adhesion
Genzyme Corporation
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 u
| Date | Jun 21, 2012 (initiated Jun 13, 2012) |
| Status | Terminated |
| Reason | Sterility of product may be compromised due to packaging defect |
| Root cause | 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 |
| Quantity | 1285 units |
| Distribution | Worldwide Distribution - US (nationwide) and the country of S. Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.