FDA recall Z-1955-2018

Dynarex Corporation · Class II · device

Product

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 for recall

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

Distribution

US Distribution to the states of : MA and NJ

Key facts

Status
Terminated
Initiation date
2018-05-08
Report date
2018-06-06
Termination date
2018-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Orangeburg, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1955-2018