Device recall
Z-0978-2024: BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code…
FDA device recall · Class II · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-0978-2024 |
|---|---|
| Recall event | 93852 |
| Product | BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. |
| Product code | KFM |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K090515 |
| 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