Events

Recall of Bard DuaLok Breast Lesion Localization Wire

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00946-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00946-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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