BEUDAMED
    FDA Enforcement Class I Terminated

    CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

    Recall: Z-0339-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0339-2023
    Event ID
    90999
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Caire, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 14, 2022
    Initiation Date
    October 10, 2022
    Classification Date
    December 2, 2022
    Termination Date
    August 19, 2024
    Address
    2200 Airport Industrial Dr Ste 500, N/A, Ball Ground, GA, 30107-4686, United States

    Description

    CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

    Reason

    An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.

    Code Info

    UDI/DI M766133374030M766132561950, Serial Numbers: CBB3022320073, CBB3022320077, CBB3022320074

    Distribution

    US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany

    Quantity

    3 units