BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2648-2014 · Initiated August 26, 2014

    Recall

    Recall Number
    Z-2648-2014
    Event Number
    69136
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    GDF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 26, 2014
    Posted
    September 16, 2014
    Terminated
    March 6, 2015
    Address
    1625 W 3rd St, Ste 109, Tempe, AZ, 85281-2438

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Worldwide Distribution-USA (nationwide), Australia, Canada, and European, Latin American and Asian Pacific countries.

    Quantity

    177,760 units