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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 80 cm Length)

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  Class 2 Device Recall FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 80 cm Length) see related information
Date Initiated by Firm April 23, 2013
Date Posted June 06, 2013
Recall Status1 Terminated 3 on June 27, 2014
Recall Number Z-1507-2013
Recall Event ID 65182
510(K)Number K081996  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product FLEXSTENT Biliary Self-Expanding Stent System.

Product Usage:
The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Code Information 27 Catalog Numbers   FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1   
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact Ivenette Guzman
786-313-2000
Manufacturer Reason
for Recall		 Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
FDA Determined
Cause 2		 Package design/selection
Action Cordis sent an Urgent Medical Device Correction and Potential Removal letter dated April 24, 2013 e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected products to prevent further use of the affected product, until inspected. ¿ Use only product identified with a blue dot next to the lot number on the carton face label, carton end label, and outer pouch label, or product with upgraded sterile barrier system (not yet available, as of the date of this letter), review, complete, sign and return the enclosed Acknowledgement Form and maintain a copy of this notice with the affected product. For questions related to the issue, please contact our FSS/Cordis representative, or please contact Cordis Direct at (800) 781-0282, Monday through Friday from 9:00 AM to 5:00 PM EDT.
Quantity in Commerce 23 units
Distribution Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
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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