Events

Rappel de Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Kerr 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-00173-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-02
  • 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-00173-1
  • 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
    Kerr corporation received complaints that cases of cure sleeves labelled with part number 4513 contained inner boxes with part number 4500. there is a low risk associated with the use of this product because the smaller sleeve size is unlikely to able to be applied to the larger tips. if the product is used; there would be a remote potential for cross contamination due to the tearing of the sleeve.
  • Action
    Kerr Corporation is contacting users to Recall affected units from the Market. This action has been closed-out on 15/07/2016.

Device

Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)
  • Modèle / numéro de série
    Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)Part Numbers: 4513C or 4513-1Kit/Refill/Syringe Lot Numbers: 201403010110ARTG Number: 161520
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd