BEUDAMED
    FDA Recall 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 · Initiated May 29, 2012

    Recall

    Recall Number
    Z-1550-2013
    Event Number
    65245
    Firm
    IDEV Technologies, Inc.
    FEI Number
    3005325609
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 29, 2012
    Posted
    June 18, 2013
    Terminated
    July 29, 2013
    Address
    253 Medical Center Blvd, Webster, TX, 77598-4213

    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.

    Action

    The firm decided to rework the products that were in their control at the time and the one that was not in their control was corrected by an IDEV employee. That hospital was called and notified of the situation in May 2012.

    Distribution

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

    Quantity

    3