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U.S. Department of Health and Human Services

Class 2 Device Recall S.M.A.R.T. CONTROL Transhepatic Biliary Stent

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 Class 2 Device Recall S.M.A.R.T. CONTROL Transhepatic Biliary Stentsee related information
Date Initiated by FirmJanuary 31, 2012
Date PostedFebruary 15, 2012
Recall Status1 Terminated 3 on August 08, 2014
Recall NumberZ-1039-2012
Recall Event ID 61098
510(K)NumberK031777 
Product Classification Catheter, biliary, diagnostic - Product Code FGE
ProductS.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.
Code Information Catalog Numbers: C09080MB, C09080SB, C10080MB, C10080SB, C12030MB, C12030SB, C12040MB, C12040SB, C12060MB, C12060SB, C12080MB, C12080SB, C14030MB, C14030SB, C14040MB, C14040SB, C14060MB, C14060SB, C14080MB, C14080SB.   
Recalling Firm/
Manufacturer
Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information ContactHal Baden
786-313-2000
Manufacturer Reason
for Recall
Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches.
FDA Determined
Cause 2
Packaging
ActionAll 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.
Quantity in Commerce18,000 units
DistributionWorldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FGE
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