Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | seprafilm® Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 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. |
|---|---|
| Recall Number | Z-1855-2012 |
| Classification | Class II |
| Code Info | Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11 |
| Product Distributed Qty | 3880units |
| Reason For Recall | Sterility of product may be compromised due to packaging defect |
Event Detail
| Event Id | 62127 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Genzyme Corporation |
| City | Framingham |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - US (nationwide) and the country of S. Korea |
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