Events

Retiro De Equipo (Recall) de Device Recall Catheter introducer

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
    57540
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0941-2011
  • Fecha de inicio del evento
    2010-12-17
  • Fecha de publicación del evento
    2011-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96488
  • 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
    Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response.
  • Acción
    Merit Medical Systems, Inc., issued an "Urgent Product Recall Notice" dated December 17, 2010, and contacted all customers (sales reps and authorized distributors) via email, phone and/or fax. The notice described the product, problem and action to be taken by the customers (Sales reps/Distributors). The customers were instructed to contact all their customers to identify, quarantine and return all unused inventory and extend the recall to any of their customers who may have received the affected products. The customers were instructed to complete and return the Manufacturer RECALL NOTIFICATION and Product Retrieval Form via fax to 1-801-208-3378 and send original to: the Manager, Customer Service, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, UT 84095-2416. Questions should be directed to the Senior Product Manager at 801-208-4344 or the Manager, Customer Service at 801-208-4365.

Device

Device Recall Catheter introducer
  • Modelo / Serial
    Lot Number: H179575
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. || 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. Can also provide access to a native or synthetic graft used for hemodialysis.
  • 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