BEUDAMED
    FDA Recall Terminated

    Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.

    Recall: Z-1261-06 · Initiated May 1, 2006

    Recall

    Recall Number
    Z-1261-06
    Event Number
    35698
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 1, 2006
    Posted
    July 27, 2006
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.

    Reason

    Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark.

    Action

    The recalling firm initiated this recall with a letter to send to their customers, via Registered Mail, on 5/1/2006. The letter requests that the customers identify and discard the potentially defective cartridges from Lot #R0299. The letter is accompanied by a recall response page to be completed by the customer and faxed or mailed back to the Radiometer so that the customer can receive an equal number of replacement cartridges free-of-charge.

    Distribution

    Nationwide.

    Quantity

    185