Events

Retiro De Equipo (Recall) de Device Recall Praxair Vantage Grab n Go

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Praxair Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63729
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0525-2013
  • Fecha de inicio del evento
    2012-11-16
  • Fecha de publicación del evento
    2012-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114654
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Regulator, pressure, gas cylinder - Product Code CAN
  • Causa
    Isolated incidents of ignition inside grab n' go cylinders that had been knocked over or otherwise subject to significant physical impact.
  • Acción
    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
  • Modelo / 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.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Praxair Inc., 39 Old Ridgebury Road, Danbury CT 06817-0001
  • Empresa matriz del fabricante (2017)
    Praxair, Inc.
  • Source
    USFDA