Drug recall
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM…
FDA recall event 89312 · Class III · LivaNova Deutschland GmbH
Key facts
| Event ID | 89312 |
|---|---|
| Recall numbers | Z-0787-2022 |
| Recalling firm | LivaNova Deutschland GmbH |
| Product type | Devices |
| Products | 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. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| Initiation date | Dec 17, 2021 |
| Report date | Mar 23, 2022 |
| Termination date | Jan 8, 2024 |
| City | Munich |
| Country | Germany |
| FEI number | 3002808267 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: