BEUDAMED
    FDA Enforcement Class II Completed

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

    Recall: Z-0479-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0479-2025
    Event ID
    95576
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Caire, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2024
    Initiation Date
    October 4, 2024
    Classification Date
    November 15, 2024
    Address
    2200 Airport Industrial Dr Ste 500, N/A, Ball Ground, GA, 30107-4686, United States

    Description

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

    Reason

    Potential failure of affected units to recharge the battery of the oxygen concentrators.

    Code Info

    UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.

    Distribution

    Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

    Quantity

    23 concentrators