BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1117-2022 · Initiated March 25, 2022

    Recall

    Recall Number
    Z-1117-2022
    Event Number
    90011
    Firm
    Caire, Inc.
    FEI Number
    3004972304
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    March 25, 2022
    Terminated
    October 5, 2023
    Address
    2200 Airport Industrial Dr, Ste 500, Ball Ground, GA, 30107-4686

    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.

    Action

    The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summarized the information that was in the email.

    Distribution

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

    Quantity

    2 oxygen concentrators