Device recall
Z-0600-2016: ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the…
FDA device recall · Class II · KCI USA, INC.
Key facts
| Recall number (Z-number) | Z-0600-2016 |
|---|---|
| Recall event | 72753 |
| Product | ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables… |
| Product code | OMP |
| Recalling firm | KCI USA, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2016 |
| FEI number | 3009897021 |
At a glance
- None 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