Z-0940-05

CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. *...

Name: Z-0940-05 CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. *...
Creator: Wilson-Cook Medical Inc
Published: 2005-06-09
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2005-06-09 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7... on 2005-06-09. The reason FDA records is "The reorder number listed on the product label is inaccurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0940-05
Status: Terminated
Initiated: 2005-06-09
Posted: 2005-06-28
Terminated: 2005-09-21
Recalling firm: Wilson-Cook Medical Inc.
Product: CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The reorder number listed on the product label is inaccurate.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by email/fax on 06/17/2005.
Quantity in commerce: 1 unit
Distribution: Brazil, Japan & Hong Kong
Product codes and lots: Lot Number: R1698831, Labeled Reorder Number CLBS-7-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)