Medical device recalls Moderate risk

Dynarex Corporation recalls Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number…

Recall date
May 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1955-2018
FDA classification
Class II
Brand / firm
Dynarex Corporation
Sold / distributed
US Distribution to the states of : MA and NJ

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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