BEUDAMED
    FDA Recall Terminated

    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

    Recall: Z-1075-2014 · Initiated July 5, 2013

    Recall

    Recall Number
    Z-1075-2014
    Event Number
    67066
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 5, 2013
    Posted
    February 24, 2014
    Terminated
    September 19, 2015
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521

    Description

    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

    Reason

    RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.

    Action

    On 7/18/2013, the firm sent Product Notification letters to their customers.

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Bermuda and Canada.

    Quantity

    38,890 units (7,860 units imported into the US)