Events

Recall of Device Recall Cook Urological Endoureterotomy Stent Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vance Products Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48760
  • Event Risk Class
    Class 2
  • Event Number
    Z-0842-2009
  • Event Initiated Date
    2008-07-31
  • Event Date Posted
    2009-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75550
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stent - Product Code FAD
  • Reason
    The bond may break where the two materials meet, resulting in separation of the stent.
  • 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.

Device

Device Recall Cook Urological Endoureterotomy Stent Set
  • Model / Serial
    Lots U1528861, U1542982, U1402436, U1361233, U1551529, U1391927, U1364946, U1347423, U1328716, U1416939, U1356437, U1525569, U1391927, U1328716, U1377093 and U1532644.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
  • Product Description
    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent.
  • Manufacturer
    Vance Products Incorporated

Manufacturer

Vance Products Incorporated
  • Manufacturer Address
    Vance Products Incorporated, 1100 W Morgan St, Spencer IN 47460-9426
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA