BEUDAMED
    FDA Recall Terminated

    D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.

    Recall: Z-1314-06 · Initiated February 1, 2005

    Recall

    Recall Number
    Z-1314-06
    Event Number
    35649
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CGZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 1, 2005
    Posted
    August 1, 2006
    Terminated
    November 18, 2011
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.

    Reason

    The CI membrane units generate too low values for status and sensitivity during calibration.

    Action

    The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.

    Distribution

    Nationwide.

    Quantity

    85/4 unit boxes