Recall Z-1955-2018— Dynarex Corporation
Class II · Terminated
Class II FDA medical device recall by Dynarex Corporation, initiated 2018-05-08, terminated 2018-09-18. FDA's recall record names no specific 510(k) clearance for this event. 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: The device is equipped with a dial that has an inaccurate flow rate indicator..
- Recalling firm
- Dynarex Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-08
- Terminated
- 2018-09-18
- Firm location
- Orangeburg, NY, United States
Product 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 for recall
The device is equipped with a dial that has an inaccurate flow rate indicator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.