Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.
FDA Recall Z-2648-2014 · Posted 2014-09-16
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Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeGDF
Date Initiated2014-08-26
Date Terminated2015-03-06
Product Quantity177,760 units
Reason for Recall
Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier.
Firm Action
A customer notification letter was sent on 8/27/14 to all customers who purchased the Bard DuaLok Breast Lesion Localization Wire. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to call Bard Peripheral's Recall Coordinator at (800) 321-4254 option#2 Ex 2727. Customers are instructed to fax the completed recall and effectiveness check form to BPV at (800) 994-6772.
Root Cause
Other
Distribution Pattern
Worldwide Distribution-USA (nationwide), Australia, Canada, and European, Latin American and Asian Pacific countries.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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