BEUDAMED
    FDA Recall Terminated

    Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" Catalog C10080MB Lot No. 15535360. Catalog C10080SB Lot No. 15530747. Catalog C12030SB Lot No. 15530756. Catalog C12040SB Lot No. 15530755. Catalog C12060SB Lot No's. 15535363, 15569685. Catalog C12080MB Lot No. 15530757 Catalog C14040SB Lot No's. 15530754, 15557313. Catalog C14060SB Lot No's. 15530753, 15557311. Catalog C14080SB Lot No. 15535361. Indicated for palliation of malignant neoplasms in the biliary tree.

    Recall: Z-1508-2012 · Initiated April 9, 2012

    Recall

    Recall Number
    Z-1508-2012
    Event Number
    61713
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 9, 2012
    Posted
    May 10, 2012
    Terminated
    December 24, 2013
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" Catalog C10080MB Lot No. 15535360. Catalog C10080SB Lot No. 15530747. Catalog C12030SB Lot No. 15530756. Catalog C12040SB Lot No. 15530755. Catalog C12060SB Lot No's. 15535363, 15569685. Catalog C12080MB Lot No. 15530757 Catalog C14040SB Lot No's. 15530754, 15557313. Catalog C14060SB Lot No's. 15530753, 15557311. Catalog C14080SB Lot No. 15535361. Indicated for palliation of malignant neoplasms in the biliary tree.

    Reason

    Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in the Tyvek packaging.

    Action

    Cordis Corp sent a " Urgent Medical Device Recall (Removal) letter dated April 9, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A Response Form was provided with each notification. Customers were asked to complete and return Response Form. The customers were instructed to : " Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. " Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. " Either return any affected product with reference to the RA# on the form, or contact your local sales representative, or contact Customer Service (see Available Assistance section) to facilitate return of the affected product. Replacement product will be provided in a short time frame. Credit will be provided for customer-owned inventory upon request. " Pass on this notice to anyone in your facility that needs to be informed. " If any product listed below has been forwarded to another facility, contact that facility to arrange return. " Maintain awareness of this notice until all product listed above has been returned to Cordis. For questions related to the issue or product replacement, please contact your local sales representative, or contact the special Customer Service number (800) 551-7683, Monday through Friday from 8:30 AM to 8:00 PM EDT.

    Distribution

    Worldwide Distribution-- USA (nationwide) and the country Canada.

    Quantity

    278 units