Events

Retiro De Equipo (Recall) de Hudson RCI One-Way Valve with Capped Monitoring Port

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical Australia Pty Ltd.

¿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
    RC-2018-RN-00307-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-04-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00307-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    It has been identified by the manufacturer that one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death.To date, there have been no injuries reported as a result of this issue.
  • Acción
    Teleflex is advising users to immediately discontinue use and quarantine any products of the affected lot numbers. Teleflex will contact customers with affected product to arrange collection of goods and provide an account credit.

Device

Hudson RCI One-Way Valve with Capped Monitoring Port
  • Modelo / Serial
    Hudson RCI One-Way Valve with Capped Monitoring PortProduct Code Number: 1644Lot Numbers: 74K1502092 and 74K1601936ARTG Number: 216042(Teleflex Medical Australia - Valve, non-rebreathing)
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd