Device recall
Z-0875-2012: ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit…
FDA device recall · Class II · Smith & Nephew Inc.
Key facts
| Recall number (Z-number) | Z-0875-2012 |
|---|---|
| Recall event | 58935 |
| Product | ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction… |
| Product code | OMP |
| Recalling firm | Smith & Nephew Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2012 |
| 510(k) numbers | K082211 |
| 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