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U.S. Department of Health and Human Services

Class 2 Device Recall S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC

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  Class 2 Device Recall S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC see related information
Date Initiated by Firm January 31, 2012
Date Posted February 15, 2012
Recall Status1 Terminated 3 on August 08, 2014
Recall Number Z-1040-2012
Recall Event ID 61098
PMA Number P020036 
Product Classification Stent, iliac - Product Code NIO
Product S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog 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 lots from 15112447 through 15525516.
Code Information Catalog Numbers: C06020ML, C06020SL, C06030ML, C06030SL, C06040ML, C06040SL, C06060ML, C06060SL, C06080ML, C06080SL, C06100ML, C06100SL, C07020ML, C07020SL, C07030ML, C07030SL, C07040ML, C07040SL, C07060ML, C07060SL, C07080ML, C07080SL, C07100ML, C07100SL, C08020ML, C08020SL, C08030ML, C08030SL, C08040ML, C08040SL, C08060ML, C08060SL, C08080ML, C08080SL, C08100ML, C08100SL, C09020ML, C09020SL, C09030ML, C09030SL, C09040ML, C09040SL, C09060ML, C09060SL, C10020ML, C10020SL, C10030ML, C10030SL, C10040ML, C10040SL, C10060ML, C10060SL.
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 initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches.
FDA Determined
Cause 2		 Packaging
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.
Quantity in Commerce 132,000 units
Distribution Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
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.
PMA Database PMAs with Product Code = NIO and Original Applicant = Cordis US Corporation
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