Events

Recall of Device Recall Pressure Monitoring Tubing

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
    67844
  • Event Risk Class
    Class 2
  • Event Number
    Z-1319-2014
  • Event Initiated Date
    2014-03-13
  • Event Date Posted
    2014-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126484
  • 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
    Pressure Monitoring Tubing - Product Code OBI
  • Reason
    The products are labeled as sterile but were not sterilized.
  • Action
    Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822.

Device

Device Recall Pressure Monitoring Tubing
  • Model / Serial
    Lot Number H591335
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
  • Product Description
    Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA