Events

Retiro De Equipo (Recall) de Device Recall Dynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlet

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 Dynarex Corporation.

¿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
    80058
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1955-2018
  • Fecha de inicio del evento
    2018-05-08
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164303
  • 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
    The device is equipped with a dial that has an inaccurate flow rate indicator.
  • Acción
    The Firm sent an Urgent Medical Device Recall letter on May 8, 2018. Customers were instructed : Customer/User should stop distributing/using product immediately. Customer/User is to complete the attached Medical Device Recall Return Response Acknowledgement and Receipt Form and return immediately using the fax number or email address on the form. After returning the form, please contact Dynarex Returned Goods Representative (see contact information on attached for or under (8) below) to return the product and to receive credit for the product. For further questions, please call ( 845 ) 365-8200.

Device

Device Recall Dynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlet
  • Modelo / Serial
    Lot number: 37979
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : MA and NJ
  • Descripción del producto
    Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 || A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • Dirección del fabricante
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962-1207
  • Empresa matriz del fabricante (2017)
    Dynarex Corporation
  • Source
    USFDA