Z-0787-2022 Class III Terminated
FDA device recall Z-0787-2022 was initiated by LivaNova Deutschland GmbH on December 17, 2021 and is designated Class III. Reason for recall: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. The recall status is terminated (terminated January 8, 2024). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2022
- Initiation Date
- December 17, 2021
- Termination Date
- January 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product 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.
Reason for Recall
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Distribution Pattern
US distribution in states of FL, TX, and NE
Code Information
CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347