Retiro De Equipo (Recall) de Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC)NUTRILINE W STYLET AND MICROFLASH

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Device technologies australia (dta) has been made aware by the manufacturer, vygon gmbh & co kg, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
  • Acción
    DTA is advising that the Instructions for Use (IFU) have been revised to provide further instructions concerning the removal of the Stylet. The relevant segment is as follows: "If difficulty is experienced removing the stylet stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously".


  • Modelo / Serial
    Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC)NUTRILINE W STYLET AND MICROFLASH Product Code: VY-1252.030 NUTRILINE TWINFLO WITH STYLET Product Code: VY-1252.230 ARTG Number: 141227(Device Technologies Australia Pty Ltd - Catheter, intravascular, general-purpose)
  • Manufacturer