Device recall
Z-2848-2016: RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains…
FDA device recall · Class II · Smith & Nephew, Inc.
Key facts
| Recall number (Z-number) | Z-2848-2016 |
|---|---|
| Recall event | 74885 |
| Product | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound… |
| Product code | OMP |
| Recalling firm | Smith & Nephew, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K061919 |
| 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