Device recall
Z-2542-2020: ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN…
FDA device recall · Class II · KCI USA, INC.
Key facts
| Recall number (Z-number) | Z-2542-2020 |
|---|---|
| Recall event | 85734 |
| Product | ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes… |
| Product code | OMP |
| Recalling firm | KCI USA, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2023 |
| 510(k) numbers | K183543 |
| 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