BEUDAMED
    FDA Recall 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 · Initiated June 23, 2015

    Recall

    Recall Number
    Z-2705-2017
    Event Number
    77528
    Firm
    O-Two Medical Technologies, Inc.
    FEI Number
    3002807836
    Product Code
    JBS
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 23, 2015
    Posted
    June 22, 2017
    Terminated
    September 1, 2017
    Address
    7575 Kimbel Street, Mississauga 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.

    Action

    O-Two Medical Technologies sent a Recall Notification on June 23, 2015, to all affected customers. The letter notified customers of the malfunctioning device, description, brand name, model/catalog number, target population, quantity, Lot Number, Shelf Life, hazard potential, and an image of labeling. The letter also provided instructions to customer for action and response. Customers were to return the affected product and O-Two will ship back the unaffected medical devices. Customers were instructed to acknowledge receipt of this recall notice by fax to 1-905-677-2035. For questions regarding this recall call 905-677-9410 or 1-800-387-3405.

    Distribution

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

    Quantity

    4382 units (4082 units distributed USA)