BEUDAMED
    FDA Recall Terminated

    Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Recall: Z-0520-2007 · Initiated January 24, 2007

    Recall

    Recall Number
    Z-0520-2007
    Event Number
    37213
    Firm
    Cook Endoscopy
    FEI Number
    1037905
    Product Code
    KNQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2007
    Posted
    February 22, 2007
    Terminated
    July 26, 2012
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Reason

    The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.

    Action

    Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.

    Distribution

    Worldwide, including NY and TX in USA, Australia, Canada and India.

    Quantity

    12 units