Device recall
Z-1596-2024: RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would…
FDA device recall · Class II · Smith & Nephew Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-1596-2024 |
|---|---|
| Recall event | 94248 |
| Product | RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139 |
| Product code | OMP |
| Recalling firm | Smith & Nephew Medical, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223041 |
| FEI number | 3002808194 |
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