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.
Z-1955-2018
Product summary
- Event
- Event 80058
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 devices
- Official record key
device-enforcement:Z-1955-2018
Official wording
Reason: The device is equipped with a dial that has an inaccurate flow rate indicator.
Code information: Lot number: 37979
Distribution pattern: US Distribution to the states of : MA and NJ
Derived failure modes
-
Unknown
The device is equipped with a dial that has an inaccurate flow rate indicator.