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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 Systemsee related information
Date Initiated by FirmDecember 05, 2007
Date PostedJuly 02, 2008
Recall Status1 Terminated 3 on January 11, 2012
Recall NumberZ-1247-2008
Recall Event ID 46679
510(K)NumberK053404 
Product Classification Biliary catheter and accessories - Product Code FGE
ProductEdwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Code Information Lot Numbers: FR6G0118 (2008/07), FR6G0119 (2008/08), FR6H0137 (Exp 2008/08), FR6H0194 (Exp 2008/08) and FR6H0203 (Exp 2008/08)
Recalling Firm/
Manufacturer		 Edwards Lifesciences, Llc
1 Edwards Way
Irvine CA 92614-5688
For Additional Information ContactWalter 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
ActionConsignees 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 CommerceLot # FR6G0118 - 3 UNITS, FR6G0119 - 2 UNITS, FR6H0137 - 5 UNITS, FR6H0194 - 2 UNITS, FR6H0203 - 4 UNITS
DistributionNationwide Distribution
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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