Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, 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-2332-2008
- Quantity
- 20 units
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
It is possible the stents inside CLSO-10-10, lot W2512492 were 5cm in length, instead of 10cm in length as listed on the product packaging label.
Distribution
Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.
Lot / Code Info
Lot number W2512492
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.