Events

Retiro De Equipo (Recall) de Device Recall Prelude Pro Sheath Introducter

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
    71519
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1826-2015
  • Fecha de inicio del evento
    2015-06-04
  • Fecha de publicación del evento
    2015-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138060
  • 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
    Dilator, vessel, for percutaneous catheterization - Product Code DRE
  • Causa
    Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. this affects one lot, h767887, of catalog number pr0-6f-11-038.
  • Acción
    Merit Medical sent an Urgent Product Recall letter on June 4, 2015, to all affected consignees. Consignees were instructed to immediately quarantine any affected devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account and a representative copy of communications sent directly to their affected accounts. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department. Customers with questions were instructed to contact their Merit Sales Representative or call (801) 208-4365.

Device

Device Recall Prelude Pro Sheath Introducter
  • Modelo / Serial
    Catalo Number PR0-6F-11-038, Lot Number H767887
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.
  • Descripción del producto
    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO || The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc
  • Source
    USFDA