BEUDAMED
    FDA Recall Terminated

    Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.

    Recall: Z-1394-2011 · Initiated September 28, 2010

    Recall

    Recall Number
    Z-1394-2011
    Event Number
    57082
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    September 28, 2010
    Posted
    February 22, 2011
    Terminated
    August 11, 2011
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.

    Reason

    A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.

    Action

    Maquet hand delivered a letter to the consignee on 10/4/2010.

    Distribution

    One hospital in New York City

    Quantity

    4 units