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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 Device Recall Praxair Vantage Grab n Gosee related information
Date Initiated by FirmNovember 16, 2012
Date PostedDecember 21, 2012
Recall Status1 Terminated 3 on March 24, 2014
Recall NumberZ-0525-2013
Recall Event ID 63729
Product Classification Regulator, pressure, gas cylinder - Product Code CAN
ProductPraxair 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 CT 06817-0001
For Additional Information Contact
203-794-2000
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		Device Design
ActionThe 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 Commerce320,451 units (255,690 US ; 55,884 Canada; 8877 OUS)
DistributionWorldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
Total Product Life CycleTPLC 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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