BEUDAMED
    FDA Recall Terminated

    Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.

    Recall: Z-0525-2013 · Initiated November 16, 2012

    Recall

    Recall Number
    Z-0525-2013
    Event Number
    63729
    Firm
    Praxair Inc.
    FEI Number
    1220594
    Product Code
    CAN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 16, 2012
    Posted
    December 21, 2012
    Terminated
    March 24, 2014
    Address
    39 Old Ridgebury Road, Danbury, CT, 06817-0001

    Description

    Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.

    Reason

    Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.

    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].

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.

    Quantity

    320,451 units (255,690 US ; 55,884 Canada; 8877 OUS)