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U.S. Department of Health and Human Services

Class 2 Device Recall S.M.A.R.T. Flex Biliary/Vascular selfexpanding stent system

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  Class 2 Device Recall S.M.A.R.T. Flex Biliary/Vascular selfexpanding stent system see related information
Date Initiated by Firm November 15, 2017
Create Date January 09, 2018
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-0324-2018
Recall Event ID 78674
510(K)Number K121125  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product Cordis S.M.A.R.T. Flex Biliary Stent System

Product Usage:
Is indicated for use in the palliation of malignant strictures in the biliary tree.
Code Information GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352,  20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 20705032066263 SF09060MB 41003 and 41359, 20705032065938 SF09060SB 41122, 20705032066096 SF09080MB 40998, 20705032066072 SF09080SB 41004 and 41202, 20705032065778 SF09100SB 40996 and 41124, 20705032065570 SF10040SB 41322, 20705032065945 SF10060SB 41002, 20705032066089 SF10080SB 41323, and  20705032066317 SF10100MB 41058.
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact Cordis Clinician
800-327-7714
Manufacturer Reason
for Recall		 Potential for cracked luer hubs
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On November 15, 2017 the firm sent letter to their customers indicating the following: The purpose of this communication is to inform you of a potential leakage scenario with the S.M.A.R.T.¿ Flex Biliary Stent System. The leak may occur due to potentially cracked hubs in some units from within the 29 lots listed in this letter. Inspection details: As stated in the Instructions for use, users are warned that the device should not be used if the outer sheath cannot be flushed. Inspect for leakage during preparation of the device. Leakage may be more likely in the affected product due to cracks in the luer. At time of actual flushing, if there is no leakage observed, the product may be safely used. Available Assistance: We can provide help if you have any questions regarding this Correction. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365.
Quantity in Commerce 511
Distribution Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of 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 = FLEXIBLE STENTING SOLUTIONS, INC.
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