Events

Retiro De Equipo (Recall) de Codan Extension Set with T Connector

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por REM Systems 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-2017-RN-00821-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-27
  • 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-2017-RN-00821-1
  • 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
    The manufacturer codan usa corporation has received isolated reports of extension sets leaking during use. the manufacturer has advised that production of the me-bc2005 has now ceased and that any stock remaining with customers should be recalled as they are potentially non-conforming.
  • Acción
    REM Systems is requesting that customers: 1. Review their inventory and quarantine all stock of the ME-BC2005 Extension sets and await replacement with an equivalent alternate set at no extra charge; and 2. Advise other relevant staff within the organisation of this issue; and 3. Complete and return the acknowledgment form supplied by REM Systems

Device

Codan Extension Set with T Connector
  • Modelo / Serial
    Codan Extension Set with T ConnectorCatalogue Number: ME-BC2005All Batch NumbersARTG Number: 126685
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd