BEUDAMED
    FDA Enforcement Class II Completed

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.

    Recall: Z-0480-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0480-2025
    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 #AS200-103.

    Reason

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

    Code Info

    No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.

    Distribution

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

    Quantity

    6 concentrators