Events

Recall of Large Bore Male Luer for use in Fluid Administration Sets.

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
    37902
  • Event Risk Class
    Class 2
  • Event Number
    Z-0845-2007
  • Event Initiated Date
    2007-04-17
  • Event Date Posted
    2007-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52157
  • 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
    IV set - Product Code FMG
  • Reason
    Male luer in fluid administration sets may crack due to inadequate molding process.
  • Action
    Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.

Device

Large Bore Male Luer for use in Fluid Administration Sets.
  • Model / Serial
    Lot Number F534043.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, IL, NJ, NY. No military, government or foreign distribution.
  • Product Description
    Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

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