Events

Recall of Device Recall Cook PTFE Wire Guide

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Urological, Inc..

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
    38283
  • Event Risk Class
    Class 2
  • Event Number
    Z-1162-2007
  • Event Initiated Date
    2007-06-12
  • Event Date Posted
    2007-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53325
  • 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/renal access guidewire - Product Code EZB
  • Reason
    Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
  • Action
    Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.

Device

Device Recall Cook PTFE Wire Guide
  • Model / Serial
    Lot U1621121
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
  • Manufacturer
    Cook Urological, Inc.

Manufacturer

Cook Urological, Inc.
  • Manufacturer Address
    Cook Urological, Inc., 1100 W Morgan St, Spencer IN 47460-9426
  • Source
    USFDA