Events

Retiro De Equipo (Recall) de NUTRILINE CATHETER WITH STYLET AND MICROFLASH

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD..

¿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
    25935
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-07-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Two vygon nutriline kits are being recalled because it was found that they were packaged with an incorrect version of the microflash introducer. the version packaged in the affected product is a ce-marked version that is not yet cleared in the us or licensed in canada. the change of introducer insider the nutriline kits was made in error as the un-licensed introducer was not approved to be in the nutriline kits.

Device

NUTRILINE CATHETER WITH STYLET AND MICROFLASH

Manufacturer

ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD.
  • Dirección del fabricante
    DORVAL
  • Source
    HC