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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Luminexx 3 Biliary Stent and Delivery System

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  Class 2 Device Recall Bard Luminexx 3 Biliary Stent and Delivery System see related information
Date Initiated by Firm July 21, 2005
Date Posted September 24, 2005
Recall Status1 Terminated 3 on October 23, 2008
Recall Number Z-1585-05
Recall Event ID 32921
510(K)Number K033497  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product Bard Luminexx 3 Biliary Stent and Delivery System
Code Information Catalog # Lot # LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060 96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937; LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 & 96DP2321
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact Shari L. Allen
480-303-2720
Manufacturer Reason
for Recall		 Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from polymer to aluminum fixtures.
FDA Determined
Cause 2		 Other
Action Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees.
Quantity in Commerce 102
Distribution Nationwide
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 = C.R. BARD, INC.
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