Events

Rappel de Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Ventilator)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Medical Australia 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-2014-RN-00567-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-27
  • 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-2014-RN-00567-1
  • 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
    Drager has become aware of cases where prior to the use of the disposable ventstar oxylog 2000 ventilation hoses, adhesive residue the size of a finger nail was found loose in the hose or the packaging around the hose; had teh hose been used with the residue in place it may have entered the patient's lungs.
  • Action
    Draeger is advising their customers to not use the hose system from the affected batches and to contact customer service to arrange for recovery and replacement.

Device

Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Venti...
  • Modèle / numéro de série
    Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Ventilator)Product Description: Packaging Box SetPart Number: 2M86841Batch Numbers: 330384.001 - 331661.002Product Description: Hose PackagingPart Number: 2M86791Batch Numbers: 330384.001 - 331661.002ARTG Number: 131796
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd