BEUDAMED
    FDA Enforcement Class II 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 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1075-2014
    Event ID
    67066
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    July 5, 2013
    Classification Date
    February 24, 2014
    Termination Date
    September 19, 2015
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521, United States

    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.

    Code Info

    Model #: 942-063 Lot #'s: R338 to R493

    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)