Events

Rappel de Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int

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-2015-RN-01155-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-27
  • 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-2015-RN-01155-1
  • 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
    Convatec have determined that specific batches of nebuliser mask products are not meeting specification. an error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. therefore the nebuliser mask will not deliver the expected therapy to the patient.
  • Action
    The sponsor ConvaTec is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor/distributor. This action has been closed-out on 26/08/2016.

Device

Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int
  • Modèle / numéro de série
    Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) intProduct Code: 1638-00Uno Multi-angle nebuliser MP T-Piece (50) intProduct Code: 1638-01Uno Aero Mask AD MA Nebuliser 210cm (50) intProduct Code: 1651-21Uno Aero Mask Child Multi-Angle Nebuliser 210cm (1x50) intProduct Code: 1654-21Multiple Lot Numbers affectedARTG Number:160226
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd