BEUDAMED
    FDA Enforcement Class III Terminated

    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.

    Recall: Z-0787-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0787-2022
    Event ID
    89312
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova Deutschland GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 23, 2022
    Initiation Date
    December 17, 2021
    Classification Date
    March 15, 2022
    Termination Date
    January 8, 2024
    Address
    Lindberghstr. 25, N/A, Munich, N/A, N/A, Germany

    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

    One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

    Code Info

    CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347

    Distribution

    US distribution in states of FL, TX, and NE

    Quantity

    4