BEUDAMED
    FDA Recall Terminated

    Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Recall: Z-0347-04 · Initiated December 22, 2003

    Recall

    Recall Number
    Z-0347-04
    Event Number
    28011
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2003
    Posted
    January 14, 2004
    Terminated
    March 23, 2004
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Reason

    Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm

    Action

    Consignee was notified by letter sent via fax on 12/19/2003.

    Distribution

    Product was shipped to one distributor in Japan.

    Quantity

    198 units