BEUDAMED
    FDA Recall Terminated

    Bayer Rapidpoint 405 Blood Gas Analyzer

    Recall: Z-0066-04 · Initiated September 26, 2003

    Recall

    Recall Number
    Z-0066-04
    Event Number
    27414
    Firm
    Bayer Corp.
    FEI Number
    3002637618
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 26, 2003
    Posted
    October 24, 2003
    Terminated
    February 4, 2004
    Address
    63 North Street, Medfield, MA, 02052-1688

    Description

    Bayer Rapidpoint 405 Blood Gas Analyzer

    Reason

    Potential for bias shift in pO2 values due to air bubble in sample path

    Action

    Bayer notified each customer by telephone and followed with a FedEx letter dated 9/26/03 providing upgraded software version 3.1 to install .

    Distribution

    Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland

    Quantity

    494 units