BEUDAMED
    FDA Recall Completed

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

    Recall: Z-0480-2025 · Initiated October 4, 2024

    Recall

    Recall Number
    Z-0480-2025
    Event Number
    95576
    Firm
    Caire, Inc.
    FEI Number
    3004972304
    Product Code
    CAW
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 4, 2024
    Posted
    November 15, 2024
    Address
    2200 Airport Industrial Dr, Ste 500, Ball Ground, GA, 30107-4686

    Description

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

    Reason

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

    Action

    The recalling firm issued letters via email on and dated 10/4/2024 to their "sold-to" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.

    Distribution

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

    Quantity

    6 concentrators