Device recall
Z-2045-2009: Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced…
FDA device recall · Class III · ConvaTec
Key facts
| Recall number (Z-number) | Z-2045-2009 |
|---|---|
| Recall event | 52814 |
| Product | Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy System; Sterile, box contains 15 units; Boehringer Wound Systems, LLC, Norristown, PA 19404 Negative Pressure Wound Therapy system is intended for the application of negative pressure to… |
| 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