BEUDAMED
    FDA Enforcement Class II Terminated

    I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

    Recall: Z-0267-2018 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0267-2018
    Event ID
    77439
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 27, 2017
    Initiation Date
    December 9, 2016
    Classification Date
    December 20, 2017
    Termination Date
    April 24, 2020
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

    Reason

    Activity and quantity of seeds sent in shipments were incorrect.

    Code Info

    Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073.

    Distribution

    Belgium & South Africa.

    Quantity

    134 seeds