Events

Retiro De Equipo (Recall) de The ARROWg+ard Blue PLUS antimicrobial catheter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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
    Recall
  • ID del evento
    RC-2018-RN-00358-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-30
  • 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-2018-RN-00358-1
  • 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
    It has been identified that certain product may have packaging that is not sealed. in the event the packaging is compromised in this manner, sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for an infection to occur. to date, teleflex medical has not received reports of this issue in australia.
  • Acción
    Teleflex is advising customers to inspect inventory for impacted lots and identify any units that appear to be affected. These units should then be discarded and Teleflex will provide a suitable credit following receipt of the acknowledgement form suppled with the customer letter.

Device

The ARROWg+ard Blue PLUS antimicrobial catheter
  • Modelo / Serial
    The ARROWg+ard Blue PLUS antimicrobial catheterMultiple Lot NumbersARTG Numbers: 138302, 136923, 278735, 278926 and 279697
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd