Events

Retiro De Equipo (Recall) de Device Recall Pressure Monitoring Tubing

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
    67844
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1319-2014
  • Fecha de inicio del evento
    2014-03-13
  • Fecha de publicación del evento
    2014-04-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126484
  • 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
    Pressure Monitoring Tubing - Product Code OBI
  • Causa
    The products are labeled as sterile but were not sterilized.
  • Acción
    Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any 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 to arrange product return and replacement. For questions call 1-801-316-4822.

Device

Device Recall Pressure Monitoring Tubing
  • Modelo / Serial
    Lot Number H591335
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
  • Descripción del producto
    Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
  • 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