Events

Recall of Device Recall MRIdium MRI Infusion Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Iradimed Corporation.

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
    63675
  • Event Risk Class
    Class 2
  • Event Number
    Z-0446-2013
  • Event Initiated Date
    2012-08-24
  • Event Date Posted
    2012-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114544
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    Iradimed corporation is recalling mridium series 1000 mr infusion sets, type 1058 mr iv extension set, lot code lbg001 because a section of the device does not meet specifications.
  • Action
    Iradimed Corporation contacted all affected customers directly by phone, and followed up with an email notification. Customers were instructed to return the product to Iradimed Corporation. For questions regarding this recall call 407-677-8022.

Device

Device Recall MRIdium MRI Infusion Sets
  • Model / Serial
    The device Lot Code is LBG001. The "L" indicates facility, Las Piedras Facility. The "B" indicates year manufactured, 2012. The "G" indicates month manufactured, July. The "001" indicates the sequential lot build, restarts at 1 every month.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
  • Product Description
    The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. || Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 || The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.
  • Manufacturer
    Iradimed Corporation

Manufacturer

Iradimed Corporation
  • Manufacturer Address
    Iradimed Corporation, 7457 Aloma Ave, Suite 201, Winter Park FL 32792-9172
  • Manufacturer Parent Company (2017)
    IRadimed Corp.
  • Source
    USFDA