Events

Recall of Device Recall Cook Harrison fetal bladder stent

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
    34671
  • Event Risk Class
    Class 2
  • Event Number
    Z-0674-06
  • Event Initiated Date
    2006-03-01
  • Event Date Posted
    2006-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44452
  • 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, Ureteral - Product Code FAD
  • Reason
    Instructions for use (ifu) booklet missing pages 5-12. pages 5-8 in english; 9-12 in danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. ifu, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. one patient booklet lacked pages 3-6, & 55-58.
  • Action
    Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received.

Device

Device Recall Cook Harrison fetal bladder stent
  • Model / Serial
    All units.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.
  • Product Description
    Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
  • Manufacturer
    Cook Urological, Inc.

Manufacturer

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