Events

Rappel de Codan Extension Set with T Connector

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par REM Systems Pty Ltd.

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
    RC-2017-RN-00821-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00821-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Codan Extension Set with T ConnectorCatalogue Number: ME-BC2005All Batch NumbersARTG Number: 126685
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd