Device recall
Z-1138-2014: PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena…
FDA device recall · Class II · KCI USA, INC.
Key facts
| Recall number (Z-number) | Z-1138-2014 |
|---|---|
| Recall event | 67454 |
| Product | PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of… |
| Product code | OMP |
| Recalling firm | KCI USA, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 6, 2015 |
| 510(k) numbers | K100821, K123878 |
| FEI number | 3009897021 |
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