Device recall
Z-1855-2012: seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product…
FDA device recall · Class II · Genzyme Corporation
Key facts
| Recall number (Z-number) | Z-1855-2012 |
|---|---|
| Recall event | 62127 |
| Product | 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… |
| Product code | MCN |
| Recalling firm | Genzyme Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2013 |
| PMA numbers | P950034 |
| FEI number | 1220423 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database