Events

Rappel de Device Recall MRIdium MRI Infusion Sets

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Iradimed Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63675
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0446-2013
  • Date de mise en oeuvre de l'événement
    2012-08-24
  • Date de publication de l'événement
    2012-11-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114544
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
  • Description du dispositif
    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
  • Adresse du fabricant
    Iradimed Corporation, 7457 Aloma Ave, Suite 201, Winter Park FL 32792-9172
  • Société-mère du fabricant (2017)
    IRadimed Corp.
  • Source
    USFDA