BEUDAMED
    FDA Recall Terminated

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.

    Recall: Z-1323-06 · Initiated September 19, 2005

    Recall

    Recall Number
    Z-1323-06
    Event Number
    35788
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 19, 2005
    Posted
    August 3, 2006
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.

    Reason

    Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.

    Action

    Following the receipt of three (3) customer complaints, on 9/14/2005, the firm issued an E-Mail notification [Management Cover] to their Service Personnel on 9/19/2005. The Management Cover instructed the service personnel to check the electrodes located at their stock and their customer locations; put all electrodes, which cannot be inserted in their call-back stock; and provide for credit to their customers through normal channels. The Service Personnel in turn, contacted their customers via telephone on or around 9/20/2005 and asked that they check their inventories for the presence of any electrodes which would not fit in the analyzer and return any such electrodes to Radiometer America for replacement

    Distribution

    Nationwide and Canada.

    Quantity

    34