Device recall
Z-1161-2014: Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s…
FDA device recall · Class II · Smith & Nephew Inc.
Key facts
| Recall number (Z-number) | Z-1161-2014 |
|---|---|
| Recall event | 67477 |
| Product | Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) |
| Product code | OMP |
| Recalling firm | Smith & Nephew Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 26, 2014 |
| 510(k) numbers | K110647 |
| 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