Events

Rappel de Device Recall PreludeEASE

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 Merit Medical Systems, Inc..

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
    75999
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0949-2017
  • Date de mise en oeuvre de l'événement
    2016-12-01
  • Date de publication de l'événement
    2017-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151906
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    Recalling dilators included with the 6f preludeease hydrophilic sheath introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.
  • Action
    Merit Medical sent an Urgent Product Recall Notice dated December 1, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify any affected devices within their facility, quarantine them, and discontinue use. Ensure that all personnel to whom the devices were distributed are made aware of this field action. Consignees were asked to work with their Merit Sales Representative to arrange product return. Consignees with questions were instructed to contact their Merit Sales Representative or Merit Customer Service at response@merit.com or at 801-208-4381. For questions regarding this recall call 801-208-4623.

Device

Device Recall PreludeEASE
  • Modèle / numéro de série
    Lots: H1014678, H1039272, H1029150, H1039269, H1029151
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    PreludeEASE Hydrophilic Sheath Introducer Dilator || The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Adresse du fabricant
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Société-mère du fabricant (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA