Flexxus Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number: LXB10060
FDA device recall Z-0730-2007 · posted 2007-04-11 · Terminated
Recall details
- Recalling firm
- Conmed Endoscopic Technologies, Inc.
- Reason for recall
- Blue safety clip incorrectly placed on the stent may prevent deployment
- Action taken
- ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 1 UNIT
- Distribution
- Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.
- Date initiated
- 2007-03-14
- Date posted
- 2007-04-11
- Date terminated
- 2007-05-15
- Location
- Billerica, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMINEXX ENDOSCOPIC BILIARY STENT (K031186) | C.R. Bard, Inc. | 2003-05-06 |