Class 2 Device Recall

• Date Initiated by Firm: July 28, 2005
• Date Posted: September 24, 2005
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-1581-05
• 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 x 60 mm Catalog Number: LXB10060
• Code Information: Lot Numbers: 96CP1390, 96CP1391, 96CP1392, 96CP1393, 96CP1988, 96CP2497, 96CP2498, 96CP1996
• 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: 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.