Device recall
Z-2043-2009: Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound…
FDA device recall · Class III · ConvaTec
Key facts
| Recall number (Z-number) | Z-2043-2009 |
|---|---|
| Recall event | 52814 |
| Product | Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; Sterile, Box Contains 10 units. Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, NJ 08558. Negative Pressure Wound Therapy system is intended for the application… |
| Product code | OMP |
| Recalling firm | ConvaTec |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 2, 2009 |
| 510(k) numbers | K061788 |
| FEI number | 3011987967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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