BEUDAMED
    FDA Recall Terminated

    S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516.

    Recall: Z-1039-2012 · Initiated January 31, 2012

    Recall

    Recall Number
    Z-1039-2012
    Event Number
    61098
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 31, 2012
    Posted
    February 15, 2012
    Terminated
    August 8, 2014
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516.

    Reason

    Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches.

    Action

    All affected consignees were notified by an "Urgent Medical Device Recall (Removal) Letter" dated January 31, 2012 and mailed by overnight delivery on February 1st and 2nd, 2012. Consignees were instructed to identify and quarantine affected product; review, complete, sign, and return an Acknowledgement Form; return the affected product per instructions. Questions should be directed to Customer Service at (800) 551-7683.

    Distribution

    Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.

    Quantity

    18,000 units