Recall of Procedure Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Reason
    Component of procedure kits may allow higher than desired amount of iv solution to be infused in to patient during pressure monitoring procedure.
  • Action
    Consignees were notified by letter on 9/2/2005.


  • Model / Serial
    Part Number: K08-01894, Lot Number A306856
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.
  • Product Description
    Merit Custom Procedure Kit
  • Manufacturer


  • Manufacturer Address
    Merit Medical Systems, Inc, 1600 West Merit Pkwy, South Jordan UT 84095-2416
  • Source