BEUDAMED
    FDA Enforcement Class II Terminated

    IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms

    Recall: Z-1550-2013 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1550-2013
    Event ID
    65245
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    IDEV Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 26, 2013
    Initiation Date
    May 29, 2012
    Classification Date
    June 18, 2013
    Termination Date
    July 29, 2013
    Address
    253 Medical Center Blvd, Webster, TX, 77598-4213, United States

    Description

    IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms

    Reason

    There was an error on the outer labeling of this device. The inner label was correct.

    Code Info

    Model Number: S-05-100-120-G3; Lot Number 01049037

    Distribution

    Nationwide Distribution to the states of FL, NY, and PA.

    Quantity

    3