Events

Recall of Device Recall Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent

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
    38273
  • Event Risk Class
    Class 2
  • Event Number
    Z-1168-2007
  • Event Initiated Date
    2007-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53295
  • 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
    ureteral stent - Product Code FAD
  • Reason
    The radiographic band may detach from the stent and remain in the patient after removal of the stent.
  • Action
    Consignees were notified of the recall via letter dated 6//29/07, which instructed them to quarantine stock on hand and to fax number on hand back to Cook for return authorization.

Device

Device Recall Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent
  • Model / Serial
    Lots U1629501, U1629502 and U1631782.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Canada, and Japan.
  • Product Description
    Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.
  • 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