Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train obstructed biliary ducts.
This recall has been terminated (originally issued September 23, 2008).
- Company
- Cook Endoscopy
- Recall Initiated
- July 2, 2008
- Posted
- September 23, 2008
- Terminated
- June 4, 2009
- Recall Number
- Z-2331-2008
- Quantity
- 20 units
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
Distribution
Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.
Lot / Code Info
Lot number W512494
Root Cause
Process control
Action Taken
Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.