BEUDAMED
    FDA Enforcement Class II Terminated

    O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    Recall: Z-2885-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2885-2018
    Event ID
    80414
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    O-Two Medical Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    May 14, 2018
    Classification Date
    August 22, 2018
    Termination Date
    June 3, 2020
    Address
    7575 Kimbel Street, Mississauga, N/A, Canada

    Description

    O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    Reason

    Higher levels of nitrous oxide delivered than specification

    Code Info

    Serial Number: EQ1332-17, EQ3001-18, EQ3003-18

    Distribution

    AK, CA, FL

    Quantity

    3 units