BEUDAMED
    FDA Recall Terminated

    Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train obstructed biliary ducts.

    Recall: Z-2331-2008 · Initiated July 2, 2008

    Recall

    Recall Number
    Z-2331-2008
    Event Number
    48970
    Firm
    Cook Endoscopy
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 2, 2008
    Posted
    September 23, 2008
    Terminated
    June 4, 2009
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train obstructed biliary ducts.

    Reason

    The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.

    Action

    Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.

    Distribution

    Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.

    Quantity

    20 units