BEUDAMED
    FDA Enforcement Class II Terminated

    CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.

    Recall: Z-0401-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0401-2018
    Event ID
    78594
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group Deutschland GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    October 30, 2017
    Classification Date
    January 19, 2018
    Termination Date
    January 26, 2024
    Address
    Lindberghstr. 25, N/A, Munich, N/A, N/A, Germany

    Description

    CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.

    Reason

    Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.

    Code Info

    Model No. 60-00-60. Drive Unit: Ref #60-01-04, UDI 04033817900948. Emergency System: Ref #60-01-35, UDI 04033817900955. Pump Control Panel: Ref #60-02-60, UDI 04033817901006.

    Distribution

    Distributed domestically to Distributed internationally to Algeria, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Jordan, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Morocco, Norway, Palestinian Territory, Panama, Peru, Poland, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, The Netherlands, Tunisia, United Kingdom, Vietnam

    Quantity

    1,318 units