BEUDAMED
    FDA Enforcement Class II Terminated

    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).

    Recall: Z-0713-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0713-2014
    Event ID
    67044
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    June 10, 2013
    Classification Date
    January 10, 2014
    Termination Date
    June 19, 2014
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521, United States

    Description

    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).

    Reason

    RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.

    Code Info

    Part #: 942-042, Lot #: R0971

    Distribution

    Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.

    Quantity

    209 boxes/6 membranes