Bard DuaLok Breast Lesion Localization Wire 의 리콜

Recall

RC-2014-RN-00946-1

Class II

2014-08-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00946-1

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.

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.