Events

Recall of Procedure Kits

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
    Recall
  • Event ID
    75367
  • Event Risk Class
    Class 2
  • Event Number
    Z-0634-2017
  • Event Date Posted
    2016-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150163
  • 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
    Single use instrument tray - Product Code OJV
  • Reason
    Merit medical systems, inc. announces a voluntary field action for various merit medical procedure kits due to a compromised sterile barrier.
  • Action
    Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.

Device

Procedure Kits
  • Model / Serial
    Lot Number: H996490
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
  • Product Description
    Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA