Device recall
Z-0787-2022: Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI…
FDA device recall · Class III · LivaNova Deutschland GmbH
Key facts
| Recall number (Z-number) | Z-0787-2022 |
|---|---|
| Recall event | 89312 |
| Product | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device. |
| Product code | DWA |
| Recalling firm | LivaNova Deutschland GmbH |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 8, 2024 |
| 510(k) numbers | K112225 |
| FEI number | 3002808267 |
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