Device recall
Z-0040-2015: RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage…
FDA device recall · Class II · Smith & Nephew, Inc.
Key facts
| Recall number (Z-number) | Z-0040-2015 |
|---|---|
| Recall event | 69146 |
| Product | RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). |
| Product code | OMP |
| Recalling firm | Smith & Nephew, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2015 |
| 510(k) numbers | K082426, K102001 |
| FEI number | 3006760724 |
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