BEUDAMED
    FDA Recall Terminated

    Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.

    Recall: Z-0038-2008 · Initiated June 22, 2007

    Recall

    Recall Number
    Z-0038-2008
    Event Number
    38511
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 22, 2007
    Posted
    October 11, 2007
    Terminated
    April 25, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.

    Reason

    Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.

    Action

    By telephone call or service representative visit beginning July 18, 2007, Consumers/End Users are asked to locate the analyzers and yearly service kits concerned and replace all pump tubes with new ones.

    Distribution

    Product was distributed throughout the United States and Canada.

    Quantity

    289 pieces