Class II — Genzyme Corporation
| Recalling firm | GENZYME CORPORATION |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Sterility of product may be compromised due to packaging defect |
| 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. |
| Quantity | 1285 units |
| Distribution | Worldwide Distribution - US (nationwide) and the country of S. Korea |
| Initiated | 2012-06-13 |
| Classified | 2012-06-21 |
| Terminated | 2013-07-24 |
| Recall number | Z-1856-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Genzyme Corporation (Z-1856-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62127/
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