BEUDAMED
    FDA Recall Terminated

    Biliary Stent Introducer Set

    Recall: Z-0908-04 · Initiated April 21, 2004

    Recall

    Recall Number
    Z-0908-04
    Event Number
    28905
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 21, 2004
    Posted
    July 20, 2004
    Terminated
    August 17, 2004
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Biliary Stent Introducer Set

    Reason

    The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.

    Action

    Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor .

    Distribution

    MO, NY, PA, Australia, Israel and England

    Quantity

    23 pieces