Flexxus Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040
This recall has been terminated (originally issued April 11, 2007).
- Recall Initiated
- March 14, 2007
- Posted
- April 11, 2007
- Terminated
- May 15, 2007
- Recall Number
- Z-0729-2007
- Quantity
- 11 UNITS
- Firm Location
- Billerica, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Blue safety clip incorrectly placed on the stent may prevent deployment
Distribution
Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.
Lot / Code Info
Lot Numbers: ANQJO636, ANQJO637
Root Cause
Other
Action Taken
ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
More recalls by Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length...
Jun 19, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm;...
Jun 19, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm;...
Jun 19, 2007