Events

Retiro De Equipo (Recall) de Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit

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-2016-RN-00736-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-02
  • 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-00736-1
  • 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
    Teleflex is recalling the neonate resuscitator with coded airway & filter resuscitator kit, as the kit was found to contain an incorrect component. the kit should be packaged with a 50mm guedel airway. however, a twin port mask was packed in the kit instead. if a 50mm guedel airway is missing from the package, this may result in a delay of treatment/airway irritation due to sub-optimal size/compromised airway. given the patient population associated with the use of this device, a delay in resuscitation has the potential to lead to adverse health consequences.
  • Acción
    Users are notified that on receipt of the acknowledgement form a return goods authorisation number will be issued and then a member of the Teleflex team will arrange collection of any affected stock from each facility. A credit will be applied to the customer account for stock returned as part of this recall. This action has been closed-out on 15/02/2017.

Device

Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit
  • Modelo / Serial
    Neonate Resuscitator with Coded Airway & Filter Resuscitator KitCatalogue Number: 99424Batch Number: 201552ARTG Number: 226699
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd