seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01… — Class II medical device recall Z-1856-2012
Terminated recall by Genzyme Corporation, reported 2012-06-27, distributed nationwide. Sterility of product may be compromised due to packaging defect
| Recall number | Z-1856-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genzyme Corporation, Framingham, MA, United States |
| Recall initiated | 2012-06-13 |
| Classified | 2012-06-21 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2013-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Quantity | 1,285 units |
| Reason classes | sterility, packaging |
| Lot numbers | 11NP685, 2014 |
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.
Reason for recall
Sterility of product may be compromised due to packaging defect
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1856-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.