Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) us...
FDA Recall #Z-0787-2022 — Class III — December 17, 2021
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.
Recalling Firm
LivaNova Deutschland GmbH — Munich, N/A
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
4
Distribution
US distribution in states of FL, TX, and NE
Code Information
CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated