BEUDAMED
    FDA Enforcement Class II Ongoing

    Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

    Recall: Z-0268-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0268-2022
    Event ID
    88877
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Western/Scott Fetzer Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 1, 2021
    Initiation Date
    October 16, 2021
    Classification Date
    November 19, 2021
    Address
    875 Bassett Rd, Westlake, OH, 44145-1142, United States

    Description

    Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

    Reason

    VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke

    Code Info

    Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)

    Distribution

    CT, MD, MT, OH

    Quantity

    4974 units