BEUDAMED
    FDA Recall Open, Classified

    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

    Recall: Z-0229-2023 · Initiated September 19, 2022

    Recall

    Recall Number
    Z-0229-2023
    Event Number
    90950
    Firm
    DeVilbiss Healthcare LLC
    FEI Number
    2515872
    Product Code
    CAW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 19, 2022
    Posted
    November 11, 2022
    Address
    100 Devilbiss Dr, Somerset, PA, 15501-2125

    Description

    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

    Reason

    An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

    Action

    DeVilbiss notified Distributors/End Users by telephone on 9/19/22. Providers of portable oxygen concentrators, identified as recipient of affected units, were contacted asking them to return any finished good units in their possession with affected serial numbers to DeVilbiss for evaluation. A replacement unit will be provided once unit possession and shipping confirmation is received. If any unit has been supplied by the provider to an end user, the provider is being requested to contact the end user to request them to stop using the unit and to replace the unit immediately. If you have any questions, call 800-338-1988.

    Distribution

    US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.

    Quantity

    48 units