BEUDAMED
    FDA Recall Terminated

    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.

    Recall: Z-3035-2018 · Initiated March 7, 2018

    Recall

    Recall Number
    Z-3035-2018
    Event Number
    80317
    Firm
    SPS Sterilization, Inc
    FEI Number
    3005057969
    Product Code
    JCT
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 7, 2018
    Terminated
    November 27, 2018
    Address
    1110 N Gerald St, Nixa, MO, 65714-7445

    Description

    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.

    Reason

    The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

    Action

    Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.

    Distribution

    US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

    Quantity

    2 units total