LivaNova Deutschland GmbH Recall 89312
Description: 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.
LivaNova Deutschland GmbH Recall 89312 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0787-2022 |
| Event ID | 89312 |
| Event Description | 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 Type | Devices |
| Distribution | US distribution in states of FL, TX, and NE |
| Quantity | 4 |
| Recall Reason | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| Device Classification | 20220323 |
| Device Code Info | CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347 |
| Center Classification Date | 20220315 |
| Recall Initiation Date | 20211217 |
| Recalling Firm | LivaNova Deutschland GmbH |
| Initial Notification | |
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