FDA Medical Device Recalls (openFDA)
Vance Products Incorporated: Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070028-14-13; GPN REF G18134. Ureteral stent. Ureteral stent.
- Recall number
- Z-0851-2009
- Recalling firm
- Vance Products Incorporated
- Product
- Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070028-14-13; GPN REF G18134. Ureteral stent. Ureteral stent.
- Status
- Terminated
- Initiated
- 2008-07-31
- Posted
- 2009-01-23
- Terminated
- 2009-11-27
- Reason
- The bond may break where the two materials meet, resulting in separation of the stent.
- 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
- 1739 of all products.
- Distribution
- Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
- Lot, serial or model codes
- Lots UF1394511, UF1546568, UF1548011, UF1550302, UF1558381, UF1562308, UF1560070, UF1531086, UF1409854, UF1390546, UF1412673, UF1388726, UF1545756, UF1549848, UF1580601, UF1588492, UF1537146, UF1564616, UF1581084, UF1389605, UF1402894 and UF1404646.
- 510(k) numbers
- ["K961446"]
- PMA numbers
- not on file
- Product code
- FAD
- Firm FEI
- 1825146
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28