BEUDAMED
    FDA Enforcement Class II Terminated

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

    Recall: Z-1117-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1117-2022
    Event ID
    90011
    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
    May 25, 2022
    Initiation Date
    March 25, 2022
    Classification Date
    May 19, 2022
    Termination Date
    October 5, 2023
    Address
    2200 Airport Industrial Dr Ste 500, N/A, Ball Ground, GA, 30107-4686, United States

    Description

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

    Reason

    The device was not cleared for U.S. distribution.

    Code Info

    Serial numbers CBB5221200337 and CBB5221200287.

    Distribution

    Distribution was made to Puerto Rico. There was no foreign/government/military distribution.

    Quantity

    2 oxygen concentrators