| Class 2 Device Recall | |
Date Initiated by Firm | July 28, 2005 |
Date Posted | September 24, 2005 |
Recall Status1 |
Terminated 3 on May 02, 2006 |
Recall Number | Z-1578-05 |
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 , 8 mm x 80 mm
Catalog Number: LXB08080 |
Code Information |
Lot Number : 96CP1385 |
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 |
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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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