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LivaNova Deutschland GmbH recalls Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 Syst
Recalled March 23, 2022 · FDA recall Z-0787-2022 · LivaNova Deutschland
Hazard
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. · FDA Class III
Units
4
Sold at
US distribution in states of FL, TX, and NE
Description
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
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.
Manufacturer(s)
LivaNova Deutschland GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →