BEUDAMED
    FDA Enforcement Class II Terminated

    Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

    Recall: Z-1955-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1955-2018
    Event ID
    80058
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dynarex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 6, 2018
    Initiation Date
    May 8, 2018
    Classification Date
    May 29, 2018
    Termination Date
    September 18, 2018
    Address
    10 Glenshaw St, N/A, Orangeburg, NY, 10962-1207, United States

    Description

    Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

    Reason

    The device is equipped with a dial that has an inaccurate flow rate indicator.

    Code Info

    Lot number: 37979

    Distribution

    US Distribution to the states of : MA and NJ

    Quantity

    15 devices