BEUDAMED
    FDA Enforcement Class II Terminated

    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

    Recall: Z-0805-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0805-2020
    Event ID
    84512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Caire, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 22, 2020
    Initiation Date
    November 21, 2019
    Classification Date
    January 13, 2020
    Termination Date
    November 20, 2020
    Address
    2200 Airport Industrial Dr Ste 500, Ball Ground, GA, 30107-4686, United States

    Description

    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

    Reason

    Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..

    Code Info

    Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280

    Distribution

    US Nationwide distribution in the states of MI, CA, CT.

    Quantity

    4 units