Device recall
Z-2044-2009: Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy…
FDA device recall · Class III · ConvaTec
Key facts
| Recall number (Z-number) | Z-2044-2009 |
|---|---|
| Recall event | 52814 |
| Product | Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, Boc 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 of… |
| 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