Events

Recall of Urodynamic Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Laborie Medical Technologies Cor.

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
    52431
  • Event Risk Class
    Class 3
  • Event Number
    Z-1711-2009
  • Event Initiated Date
    2009-04-09
  • Event Date Posted
    2009-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82974
  • 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
    Cystometer, electrical recording - Product Code EXQ
  • Reason
    Laborie medical technologies reports that there was a mix up in the labeling and packaging of their urodynamic catheters. there were 8fr catheters mixed inside the 6fr catheter packages.
  • Action
    Laborie Medical Technologies notified customers by telephone/email beginning April 10, 2009 advising them of the mislabelled product. For further questions, contact Laborie Medical Technologies at 1-800-522-6743.

Device

Urodynamic Catheters
  • Model / Serial
    Lot Number: 82484.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA, GA, IL, KS, MD, PA, OH, OK, UT and WA.
  • Product Description
    Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
  • Manufacturer
    Laborie Medical Technologies Cor

Manufacturer

Laborie Medical Technologies Cor
  • Manufacturer Address
    Laborie Medical Technologies Cor, 400 Avenue D Ste 10, Williston VT 05495-7828
  • Source
    USFDA