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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 28, 2005
Date Posted September 24, 2005
Recall Status1 Terminated 3 on May 02, 2006
Recall Number Z-1583-05
Recall Event ID 32853
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product Bard¿ Luminexx¿ Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x100 mm
Catalog Number: LXB10100
Code Information Lot Number : 96CP2508
Recalling Firm/
Manufacturer		 Angiomed Gmbh
Wachhausstrasse 6
Karlsruhe Germany
For Additional Information Contact Beth Zis
978-262-4251
Manufacturer Reason
for Recall		 Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
FDA Determined
Cause 2		 Other
Action On 7/26/05, Angiomed notified by telephone and follow-up letter Conmed Endoscopic Technologies, Billerica, MA [ the US distributor of the Bard¿ Luminexx¿ Endoscopic Biliary Stent ]. ConMed has issued recall notification letters dated 7/28/05 to the US customers of this recall.
Quantity in Commerce 204 units
Distribution Natiowide
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.
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