Events

Retiro De Equipo (Recall) de Pennine Healthcare Ryles Tubes (used for enteral feeding)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bosco Medical Australia.

¿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
    RC-2016-RN-01156-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01156-1
  • 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
    Bosco medical australia pty ltd have been notified by the manufacturer that there is a possibility that a tube could have the print graduations running the wrong way, i.E. they decrease with distance from the tip of the tube, when the correct orientation is that the numbers increase with distance from the tip of the tube. there is the potential for misplacement of the tubes if the print graduations are used as the sole means for confirming the placement of the ryles tube.
  • Acción
    Bosco Medical is advising users to inspect the graduations of the tubes prior to insertion. If affected product is found, replace with unaffected product and contact Bosco for credit or replacement.

Device

Pennine Healthcare Ryles Tubes (used for enteral feeding)
  • Modelo / Serial
    Pennine Healthcare Ryles Tubes (used for enteral feeding)Multiple products affected Product Codes: RT-2008/L, RT-2010/L, RT-2012/L, RT-2014/L, RT-2016/L, RT-2018/L, RT-2314, RT-2316All Lot Numbers affectedARTG Number: 144359
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia