Device recall
Z-1209-2019: Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as…
FDA device recall · Class II · Fenwal Inc
Key facts
| Recall number (Z-number) | Z-1209-2019 |
|---|---|
| Recall event | 82395 |
| Product | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444… |
| Product code | CAC |
| Recalling firm | Fenwal Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K160735 |
| 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