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U.S. Department of Health and Human Services

Class 2 Device Recall Dynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlet

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  Class 2 Device Recall Dynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlet see related information
Date Initiated by Firm May 08, 2018
Create Date May 29, 2018
Recall Status1 Terminated 3 on September 18, 2018
Recall Number Z-1955-2018
Recall Event ID 80058
Product Classification Regulator, pressure, gas cylinder - Product Code CAN
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.
Code Information Lot number: 37979
Recalling Firm/
Manufacturer		 Dynarex Corporation
10 Glenshaw St
Orangeburg NY 10962-1207
For Additional Information Contact
845-365-8200
Manufacturer Reason
for Recall		 The device is equipped with a dial that has an inaccurate flow rate indicator.
FDA Determined
Cause 2		 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 ) 365-8200.
Quantity in Commerce 15 devices
Distribution US Distribution to the states of : MA and NJ
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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