Z-2331-2008

Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only...

Name: Z-2331-2008 Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only...
Creator: Cook Endoscopy
Published: 2008-07-02
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2008-07-02 / Terminated / root cause: manufacturing process

FDA source

Cook Endoscopy began a recall of 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... on 2008-07-02. The reason FDA records is "The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2331-2008
Status: Terminated
Initiated: 2008-07-02
Posted: 2008-09-23
Terminated: 2009-06-04
Recalling firm: Wilson-Cook Medical Inc.
Product: 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.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.
Product codes and lots: Lot number W512494

Product code FGE

K851962Class IIZimmon Biliary Stent SetWilson-Cook Medical, Inc. / cleared 1985-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)