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Terminated

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.

FDA Recall Z-1955-2018 · Posted None

Recalling FirmDynarex Corporation
Recall StatusTerminated
Product CodeCAN
Date Initiated2018-05-08
Date Terminated2018-09-18
Product Quantity15 devices

Reason for Recall

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

Firm 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 ) 365-8200.

Root Cause

Process control

Distribution Pattern

US Distribution to the states of : MA and NJ

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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