BEUDAMED
    FDA Recall Terminated

    D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.

    Recall: Z-1406-06 · Initiated January 12, 2005

    Recall

    Recall Number
    Z-1406-06
    Event Number
    35664
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2005
    Posted
    August 26, 2006
    Terminated
    September 14, 2011
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.

    Reason

    QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.

    Action

    The firm contacted their customers and informed them of this problem and provided a workaround procedure, in a a letter dated 1/12/2005. A ''Field Action Notification'' (FAN) was issued to the firm''s Field Service personnel on 1/21/2005. The letter instructs their personnel to update the NPT7 application software on all units to V3.05 and to hand over a copy of the letter ''Changes related to the Qualicheck2+ and NPT7,'' to the user/customers. In addition, the firm''s personnel were instructed to remove any of the suspect cartridges found on-hand at each customer location; destroy them;and replace them with different lot numberd product.

    Distribution

    The recalled device component was distributed to a total of 56 customers, nationwide located in the following states: AL, AR, AZ, CA, CO, GA, ID, IL, KA, MA, ME, MI, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT & WA.

    Quantity

    545