Device recall
Z-0342-2011: The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS…
FDA device recall · Class II · Fresenius Kabi, LLC
Key facts
| Recall number (Z-number) | Z-0342-2011 |
|---|---|
| Recall event | 56751 |
| Product | The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF120 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and… |
| Product code | CAC |
| Recalling firm | Fresenius Kabi, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 2011 |
| 510(k) numbers | K960006 |
| FEI number | 3007344667 |
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