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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards LifeStent FlexStar Biliary Stent System

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  Class 2 Device Recall Edwards LifeStent FlexStar Biliary Stent System see related information
Date Initiated by Firm December 05, 2007
Date Posted July 02, 2008
Recall Status1 Terminated 3 on January 11, 2012
Recall Number Z-1246-2008
Recall Event ID 46679
510(K)Number K053404  
Product Classification Biliary catheter and accessories - Product Code FGE
Product Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Code Information Lot Numbers: FR6F0111 (Exp 2008/06), FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08), FR6H0135 (Exp 2008/08), FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08)
Recalling Firm/
Manufacturer		 Edwards Lifesciences, Llc
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Walter Wiegand
949-250-2443
Manufacturer Reason
for Recall		 Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.
Quantity in Commerce Lot Code FR6F0111 - 1 UNIT, FR6G0120 - 3 UNITS, FR6G0121 - 4 UNITS, FR6H0135 - 2 UNITS, FR6H0182 - 5 UNITS, FR6H0192 - 3 UNITS
Distribution Nationwide Distribution
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 = EDWARDS LIFESCIENCES, LLC.
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