BEUDAMED
    FDA Recall Terminated

    MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. .

    Recall: Z-1900-2017 · Initiated March 28, 2017

    Recall

    Recall Number
    Z-1900-2017
    Event Number
    76914
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    GDF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2017
    Posted
    May 2, 2017
    Terminated
    June 29, 2017
    Address
    1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438

    Description

    MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. .

    Reason

    It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.

    Action

    Bard sent an Urgent Medical Device Recall notification letter dated March 28, 2017 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact your Bard representative.

    Distribution

    Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium.

    Quantity

    570 units