Events

Rappel de EnCor Probes (used for breast biopsies)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard 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-2016-RN-00490-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-22
  • 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-2016-RN-00490-1
  • 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
    Bard peripheral vascular (bpv) has confirmed that the affected lot numbers may be at risk of having an incorrect sample trap assembly. a portion of the affected lots may contain units with incorrect sample trap assemblies affixed to the probe inside the product tray (a lateral assembly instead of an upright assembly). the labelling on the outer product carton and inside packaging tray is correct. specifically, the issue is that the incorrect sample trap assembly contains shorter vacuum tubing and no clear tray cover.The potential harm associated with attempting to use this device labelled for upright use may result in the sample trap assembly being filled with fluid during use and when removing the sample collection tray (basket), the sample(s) may fall out of the collection tray because of the lack of a cover.
  • Action
    Bard is advising users to inspect the affected lots before use to ensure the correct trap assembly is affixed to the probe. This action has been closed-out on 30/01/2017.

Device

EnCor Probes (used for breast biopsies)
  • Modèle / numéro de série
    EnCor Probes (used for breast biopsies)Biopsy Probe – 10g VerticalEnd Item Code: ECP0110GVLot Numbers: VT14G0223, VT15F0266, VT15G0345, VT15K0439, VT15L0482, VT15M0572Biopsy Probe – 12g VerticalEnd Item Code: ECP0112GVLot Number: VT15E0244ARTG Number: 154530
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd