Events

Rappel de Bard DuaLok Breast Lesion Localization Wire

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-2014-RN-00946-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-29
  • 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-2014-RN-00946-1
  • 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 identified that some product code and lot number combinations may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier. an exposed bard dualok breast lesion localisation wire has the potential to cause an inadvertent mid penetrating or laceration injury during handling of the packaging. the use of a bard dualok breast lesion localisation wire, after a portion of the wire has breached the sterile barrier, could potentially pose an incremental risk of harm including complications associated with localised or systemic infection which may require medical intervention to preclude a serious injury.
  • Action
    Customers are advised to not use or further distribute any affected product and to remove any identified product from their shelves. Bard is also advising to closely monitor patients who are known to have been treated utilising the affected localisation wires and may still be at risk of developing infectious complications. Medical management should be at the discretion of the treating physician. This action has been closed-out on 01/03/2016.

Device

Bard DuaLok Breast Lesion Localization Wire
  • Modèle / numéro de série
    Bard DuaLok Breast Lesion Localization Wire Part Numbers: LW0037, LW0057, LW0077, LW0107 & LW0137Multiple lot numbersARTG number: 135463
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd