BEUDAMED
    FDA Recall Terminated

    CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

    Recall: Z-0338-2023 · Initiated October 10, 2022

    Recall

    Recall Number
    Z-0338-2023
    Event Number
    90999
    Firm
    Caire, Inc.
    FEI Number
    3004972304
    Product Code
    BYJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 10, 2022
    Posted
    December 2, 2022
    Terminated
    August 19, 2024
    Address
    2200 Airport Industrial Dr, Ste 500, Ball Ground, GA, 30107-4686

    Description

    CAIRE Liberator 30, MODEL 13337403, 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.

    Action

    The firm issued an URGENT: MEDICAL DEVICE RECALL notice its consignees be email and telephone. The notice explained the issue and requested the removal of the affected products from the field and return to CAIRE. CAIRE will immediately replace the above serial numbers with new Liberator devices. Please contact CAIRE Customer Service via phone at 1-800-482-2473 or 770-721-7700 or via email at [email protected] to arrange for the return and replacement of the above serial numbers.

    Distribution

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

    Quantity

    5 devices