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U.S. Department of Health and Human Services

Class 2 Device Recall Transhepatic Biliary Stent System

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  Class 2 Device Recall Transhepatic Biliary Stent System see related information
Date Initiated by Firm April 09, 2012
Date Posted May 10, 2012
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1508-2012
Recall Event ID 61713
510(K)Number K042969  K031777  K062798  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product 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.
Code Information Lot No's. 15535360, 15530747, 15530756, 15530755, 15535363, 15569685, 15530757, 15530754, 15557313, 15530753, 15557311, 15535361.    
Recalling Firm/
Manufacturer
Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact Hal Baden
786-313-2000
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Packaging process control
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.
Quantity in Commerce 278 units
Distribution Worldwide Distribution-- USA (nationwide) and the country Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = CORDIS CORP.
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