BEUDAMED
    FDA Enforcement Class II Ongoing

    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    Recall: Z-0221-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0221-2022
    Event ID
    88821
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    October 1, 2021
    Classification Date
    November 12, 2021
    Address
    14201 NW 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    Reason

    There is a potential for distal tip dislodgement or separation.

    Code Info

    Product Code: SF10100MB; Lot No. 271626

    Distribution

    US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.

    Quantity

    4 units