BEUDAMED
    FDA Recall Terminated

    D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)

    Recall: Z-1436-06 · Initiated November 1, 2005

    Recall

    Recall Number
    Z-1436-06
    Event Number
    35789
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    KLK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2005
    Posted
    August 31, 2006
    Terminated
    April 25, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)

    Reason

    Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations

    Action

    The firm decided to initiate a recall on 9/8/2005 and the recall letter was issued in November, 2005. The letter informs the customers of this problem and asks that each customer inspect their current stock for the presence of the recalled lot codes and discard any such product found. The letter is accompanied by a recall response form which the customer can use to request additional replacement ellectrodes as necessary.

    Distribution

    Worldwide distribution --- including the states of PA, IL, TX, NY, FL, KS, NE, AL, MI, LA, WI, MN, NJ, CA, NH, MD, OH, MO, UT, IN, GA, WA, MA, KY, NC, IA, OK, SD, CO, AR, SC, ME, NV, AZ, RI, AK, MS, VA, WV, MT, TN, IN & NM. Country List pending

    Quantity

    3,323-USA, 1,197-Foreign