Events

Retiro De Equipo (Recall) de Device Recall PreludeEASE

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 Merit Medical Systems, Inc..

¿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
    75999
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0949-2017
  • Fecha de inicio del evento
    2016-12-01
  • Fecha de publicación del evento
    2017-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151906
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Lots: H1014678, H1039272, H1029150, H1039269, H1029151
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    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.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA