Events

Retiro De Equipo (Recall) de ProTrack Microcatheter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pacing Importers 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-2017-RN-01417-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-15
  • 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-2017-RN-01417-1
  • 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
    There is a chance that the affected catheters may have circumferential cracks along its length.If the cracks are present on the device, they are likely to be detected by a physician upon removal of the catheter from the packaging. the cracks may result in leakage of fluids along the catheter. there have been no adverse event reports related to this discovery.
  • Acción
    Baylis Medical is advising users to inspect stock and quarantine any unused units for return.

Device

ProTrack Microcatheter
  • Modelo / Serial
    ProTrack MicrocatheterPart number: CIC35-145Lot Numbers: CIFA131113, CIFA100614, CIFA100714, CIFA241014Part number: CIC38-145Lot Numbers: CIFA161013, CIFA240614, CIFA.271113, CIFA100714, CIFA311213, CIFA180814, CIFA210214, CIFA080914, CIFA070314, CIFA.221014, CIFA270314, CIFA050115, CIFA070514, CIFA210115, CIFA210514, CIFA060215ARTG Number: 185946
  • Manufacturer
    Pacing Importers Pty Ltd

Manufacturer

Pacing Importers Pty Ltd
  • Source
    DHTGA