Events

Rappel de Allersearch Economist Forte Nebuliser (non heated nebuliser)

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

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-2012-RN-00764-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-06
  • 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-2012-RN-00764-3
  • 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
    It is recongnised that there is an issue with the economist forte and the fit to the unit with the supplied power cord accessory. in some cases, the power cord moulding is too large to fit into the unit. it is necessary to state that there is no safety issue with the unit, other than the possibility of the device not working due to lack of power supply.
  • Action
    The sponsor is asking pharmacies to return all affected stock to their wholesaler. The sponsor is asking all wholesalers to quarantine affected stock for return.

Device

Allersearch Economist Forte Nebuliser (non heated nebuliser)
  • Modèle / numéro de série
    Allersearch Economist Forte Nebuliser (non heated nebuliser)Catalogue Number: AE650-040Batch Numbers: 11AD12 and 11AD12AARTG Number: 98386
  • Manufacturer
    Ebos Group Pty Limited

Manufacturer

Ebos Group Pty Limited