Events

Retiro De Equipo (Recall) de Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous 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-2015-RN-00729-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-12
  • 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-2015-RN-00729-1
  • 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
    The reason for this action is due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. the component tabs extend past the opening to the sheath, so even if both tabs break, there will be some length of the sheath that would protrude from the skin. therefore, embolus of the sheath should not occur. the defect is easy to recognise and the clinician would have the choice of either continuing with the split sheath or using a new one. although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.
  • Acción
    Customers are advised not to use or distribute any affected stock and immediately quarantine them. Teleflex Medical will arrange collection of any affected stock from affected facilities. This action has been closed-out on 18/08/2016.

Device

Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central v...
  • Modelo / Serial
    Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter)Catalogue number: PI-01451-LSBatch Numbers: 23F14J0437, 23F14K0406, 23F14B0935, 23F14H1535, 23F15A0278, 23F15D0907ARTG Number: 148783
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd