FDA-Device2022-03-23Class III
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
Hazard
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Sold states
US distribution in states of FL, TX, and NE
Affected count
4
Manufactured in
Lindberghstr. 25, N/A, Munich, N/A, Germany
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0787-2022Don't want to check this manually?
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