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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/
Angiomed Gmbh
Wachhausstrasse 6
Karlsruhe Germany
For Additional Information Contact Beth Zis
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
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.