Device recall
Z-1059-2019: Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous…
FDA device recall · Class II · Fenwal Inc
Key facts
| Recall number (Z-number) | Z-1059-2019 |
|---|---|
| Recall event | 82194 |
| Product | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. |
| Product code | CAC |
| Recalling firm | Fenwal Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 23, 2020 |
| 510(k) numbers | K180831 |
| FEI number | 3004548776 |
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