Medical Device
Manufacturing
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Z-0525-2013Class I

Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator...

Praxair, Inc. / initiated 2012-11-16 / Terminated / root cause: design

Praxair Inc. began a recall of Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder on . FDA classified it as Class I and gives the reason as "Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0525-2013
Classification
Class I
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Praxair, Inc.
Product
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
Product code
CAN Regulator, Pressure, Gas Cylinder
Reason for recall
Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Root cause tag
design
FDA root cause
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: [email protected].
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.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0525-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0525-2013Class ITerminatedVoluntary: Firm initiated