BEUDAMED
    FDA Recall Terminated

    CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.

    Recall: Z-0940-05 · Initiated June 9, 2005

    Recall

    Recall Number
    Z-0940-05
    Event Number
    32422
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 9, 2005
    Posted
    June 28, 2005
    Terminated
    September 21, 2005
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.

    Reason

    The reorder number listed on the product label is inaccurate.

    Action

    Consignees were notified by email/fax on 06/17/2005.

    Distribution

    Brazil, Japan & Hong Kong

    Quantity

    1 unit