Device recall
Z-0678-2020: Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The…
FDA device recall · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-0678-2020 |
|---|---|
| Recall event | 84377 |
| Product | Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. |
| Product code | KFM |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2020 |
| 510(k) numbers | K991864 |
| FEI number | 3008355164 |
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