Device recall
Z-1814-2009: ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound…
FDA device recall · Class III · ConvaTec
Key facts
| Recall number (Z-number) | Z-1814-2009 |
|---|---|
| Recall event | 52680 |
| Product | ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box. |
| 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