Events

Recall of Device Recall Praxair Vantage Grab n Go

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Praxair Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63729
  • Event Risk Class
    Class 1
  • Event Number
    Z-0525-2013
  • Event Initiated Date
    2012-11-16
  • Event Date Posted
    2012-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114654
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Regulator, pressure, gas cylinder - Product Code CAN
  • 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: Thelma_Brantley@Praxair.com.

Device

Device Recall Praxair Vantage Grab n Go
  • Model / Serial
    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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
  • Product Description
    Praxair Vantage Grab n Go - Gas Cylinder pressure regulator || Catalog Number: OX-M-AEGNGVNTG || Usage: Regulator reduces pressure in oxygen-containing cylinder.
  • Manufacturer
    Praxair Inc.

Manufacturer

Praxair Inc.
  • Manufacturer Address
    Praxair Inc., 39 Old Ridgebury Road, Danbury CT 06817-0001
  • Manufacturer Parent Company (2017)
    Praxair, Inc.
  • Source
    USFDA