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U.S. Department of Health and Human Services

Class 1 Device Recall Praxair Vantage Grab n Go

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 Class 1 Recall
Praxair Vantage Grab n Go
see related information
Date Posted December 21, 2012
Recall Status1 Terminated on March 24, 2014
Recall Number Z-0525-2013
Recall Event ID 63729
Product Classification Regulator, Pressure, Gas Cylinder - Product Code CAN
Product Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
Code Information OX M-AEGNGVNTG (US and Canada) and WESPRX-9500 (Global) Cyclinders in service since Jan 2009. Units with a "T" decal (T-teflon) on the fill side of the valve have the rework completed.
Recalling Firm/
Manufacturer
Praxair Inc.
39 Old Ridgebury Road
Danbury, Connecticut 06817-0001
Manufacturer Reason
for Recall
Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, PRAXAIR, sent a "MEDICAL DEVICE CORRECTION" letter dated November 26, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the Grab'n Go operating instructions provided in the letter which include: storing the Grab'n Go systems indoors in a safe area; never store a system in an elevated location; handle systems safely and avoid jarring or dropping the system and locate at the following web link: www.praxair.com/GNGinstructions. The customers were also instructed to ensure that all of the Grab'n Go units that were sent by Praxair are sent to Praxair for servicing and refilling after use, in accordance with their normal process. If you have any questions, contact your sales representative at 630-320-4452 or email: Thelma_Brantley@Praxair.com.
Quantity in Commerce 320,451 units (255,690 US ; 55,884 Canada; 8877 OUS)
Distribution Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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