Z-0850-2009

Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer...

Name: Z-0850-2009 Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer...
Creator: Vance Products Incorporated
Published: 2008-07-31
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2008-07-31 / Terminated / root cause: manufacturing process

FDA source

Vance Products Incorporated began a recall of Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070026-14-13; GPN REF G18127... on 2008-07-31. The reason FDA records is "The bond may break where the two materials meet, resulting in separation of the stent". 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-0850-2009
Status: Terminated
Initiated: 2008-07-31
Posted: 2009-01-23
Terminated: 2009-11-27
Recalling firm: Cook Incorporated
Product: Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent.
Product code: FAD Stent, Ureteral
Reason for recall: The bond may break where the two materials meet, resulting in separation of the stent.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified via "Urgent: Recall Notice" letter dated 7/31/08. The letter described the failure, instructed that the products be isolated and returned to the firm. For additional information, contact Cook Urological at 1-812-339-2235, ext. 7241.
Quantity in commerce: 1739 of all products.
Distribution: Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
Product codes and lots: Lots U1415656, U1392361, U1343299, U1416941, U1371126, U1363042, U1409768, U1405040, U1546157, U1414495, U1347427, U1551531, U1571113, U1533048, U1525573, U1535611 and U1409768S.

Product code FAD

K961446Class IIAq Hydrophilic StentCook Urological, Inc. / cleared 1996-05-28

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)