Events

Rappel de Device Recall Praxair Vantage Grab n Go

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Praxair Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63729
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0525-2013
  • Date de mise en oeuvre de l'événement
    2012-11-16
  • Date de publication de l'événement
    2012-12-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114654
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Regulator, pressure, gas cylinder - Product Code CAN
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Praxair Inc., 39 Old Ridgebury Road, Danbury CT 06817-0001
  • Société-mère du fabricant (2017)
    Praxair, Inc.
  • Source
    USFDA