Recall Z-1955-2018 ยท CAN Regulator, Pressure, Gas Cylinder
Dynarex Corporation
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 oxyge
| Date | May 8, 2018 |
| Status | Terminated |
| Reason | The device is equipped with a dial that has an inaccurate flow rate indicator. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 15 devices |
| Distribution | US Distribution to the states of : MA and NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.