Events

Recall of Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0

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
    25427
  • Event Risk Class
    Class 2
  • Event Number
    Z-0554-03
  • Event Initiated Date
    2003-01-22
  • Event Date Posted
    2003-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25814
  • 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
    Dilator, Catheter, Ureteral - Product Code EZN
  • Reason
    Product is labeled sterile, but was not sterilized.
  • Action
    Customers were notified by phone call and recall letter beginning on 1/22/03.

Device

Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
  • Model / Serial
    Lot 1049345
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.
  • Product Description
    Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
  • Manufacturer
    Cook Urological, Inc.

Manufacturer

Cook Urological, Inc.
  • Manufacturer Address
    Cook Urological, Inc., 1100 West Morgan, Spencer IN 47460
  • Source
    USFDA