Events

Retiro De Equipo (Recall) de Device Recall MRIdium MRI Infusion Sets

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Iradimed Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63675
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0446-2013
  • Fecha de inicio del evento
    2012-08-24
  • Fecha de publicación del evento
    2012-11-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114544
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    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.
  • Acción
    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
  • Modelo / 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.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
  • Descripción del producto
    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
  • Dirección del fabricante
    Iradimed Corporation, 7457 Aloma Ave, Suite 201, Winter Park FL 32792-9172
  • Empresa matriz del fabricante (2017)
    IRadimed Corp.
  • Source
    USFDA