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.
- Company
- Dynarex Corporation
- Recall Initiated
- May 8, 2018
- Terminated
- September 18, 2018
- Recall Number
- Z-1955-2018
- Quantity
- 15 devices
- Firm Location
- Orangeburg, NY
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
Lot / Code Info
Lot number: 37979
Root Cause
Process control
Action Taken
The Firm sent an Urgent Medical Device Recall letter on May 8, 2018. Customers were instructed : Customer/User should stop distributing/using product immediately. Customer/User is to complete the attached Medical Device Recall Return Response Acknowledgement and Receipt Form and return immediately using the fax number or email address on the form. After returning the form, please contact Dynarex Returned Goods Representative (see contact information on attached for or under (8) below) to return the product and to receive credit for the product. For further questions, please call ( 845 ) 365-8200.