BEUDAMED
    FDA Enforcement Class II Ongoing

    OxyMask O2 Adult REF OM-1125-14

    Recall: Z-2141-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2141-2021
    Event ID
    88103
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Southmedic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 4, 2021
    Initiation Date
    May 25, 2021
    Classification Date
    July 23, 2021
    Address
    50 Alliance Blvd, N/A, Barrie, N/A, N/A, Canada

    Description

    OxyMask O2 Adult REF OM-1125-14

    Reason

    Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.

    Code Info

    Model: OM-1125-14 Lot Number: W73887

    Distribution

    U.S.: IL O.U.S.: N/A

    Quantity

    160 cases (25 units per case) in U.S.