Cook Endoscopy 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Cook Endoscopy
Lot Codes / Batch Numbers
Lot number W2512492
Products Sold
Lot number W2512492
Cook Endoscopy is recalling Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use only, Rx due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MO, NV, NC, TX, UT
Page updated: Jan 10, 2026