BEUDAMED
    FDA Enforcement Class II Terminated

    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

    Recall: Z-2705-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2705-2017
    Event ID
    77528
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    O-Two Medical Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    June 23, 2015
    Classification Date
    July 10, 2017
    Termination Date
    September 1, 2017
    Address
    7575 Kimbel Street, Mississauga, N/A, Canada

    Description

    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

    Reason

    Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.

    Code Info

    Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016

    Distribution

    Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland

    Quantity

    4382 units (4082 units distributed USA)