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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00946-1
Product Name/Description	Bard DuaLok Breast Lesion Localization Wire Part Numbers: LW0037, LW0057, LW0077, LW0107 & LW0137 Multiple lot numbers ARTG number: 135463
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/08/2014
Responsible Entity	Bard Australia Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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.
Contact Information	1800 257 232 - Bard Australia Customer Service