Events

Rappel de Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7') Oxygen Tubing

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ConvaTec 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-2017-RN-00649-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-06-26
  • 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-00649-1
  • 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
    An internal assessment of product reports by convatec has confirmed that specific high concentration oxygen masks have an issue whereby the tubing has been found to disconnect from the oxygen mask, prior to use or during use, causing a disruption in supply of oxygen.
  • Action
    ConvaTec is requesting that customers quarantine affected product in their inventory. ConvaTec will organise for product returns and credit.

Device

Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration wi...
  • Modèle / numéro de série
    Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7') Oxygen TubingProduct Code: 108MMBatch Numbers: 106253 and 112025Non-Rebreather Oxygen Mask, Paediatric High Concentration with 2.1 m (7') Oxygen TubingProduct Code: 3230MMBatch Number: 13-20ARTG Number: 189280
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd