BEUDAMED
    FDA Recall Terminated

    SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.

    Recall: Z-1213-2012 · Initiated January 31, 2012

    Recall

    Recall Number
    Z-1213-2012
    Event Number
    61090
    Firm
    Idev Technologies, Inc.
    FEI Number
    3005325609
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 31, 2012
    Posted
    March 15, 2012
    Terminated
    September 9, 2013
    Address
    253 Medical Center Blvd, Webster, TX, 77598

    Description

    SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.

    Reason

    The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).

    Action

    IDEV Technologies sent an "URGENT PRODUCT RECALL" letter dated February 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to sign the letter and return a copy to the firm via fax to 281-525-2001 to indicate that they have received the notification. Contact the firm at 281-525-2052 for questions regarding the notice.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA.

    Quantity

    Seven devices