BEUDAMED
    FDA Recall 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 · Initiated October 30, 2017

    Recall

    Recall Number
    Z-0401-2018
    Event Number
    78594
    Firm
    Sorin Group Deutschland GmbH Lindberghstr. 25 Munich Germany
    FEI Number
    3002808267
    Product Code
    DWA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 30, 2017
    Terminated
    January 26, 2024

    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.

    Action

    Consignees were notified of the recall via USPS trackable mail, beginning on 10/30/2017. The letter informed customers Instructions included to continue following the Instructions for use, including use of an arterial filter on the arterial line, and that a LivaNova representative will contact them to schedule an upgrade to their device.

    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