Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog Number: LXB08060
FDA device recall Z-1577-05 · posted 2005-09-24 · Terminated
Recall details
- Recalling firm
- Angiomed Gmbh
- Reason for recall
- Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 204
- Distribution
- Natiowide
- Date initiated
- 2005-07-28
- Date posted
- 2005-09-24
- Date terminated
- 2006-05-02
- Location
- Karlsruhe, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMINEXX ENDOSCOPIC BILIARY STENT (K031186) | C.R. Bard, Inc. | 2003-05-06 |