Events

Retiro De Equipo (Recall) de 4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer) Product Description: STF 4F M.I. KIT 45CM NT/T ECHO S PG

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical Specialties 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-01295-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-11
  • 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-01295-1
  • 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
    Angiodynamics, inc., the manufacturer of the 4f stiffened micro-introducer kits, has become aware of the potential with respect to the 4f sheath/dilator components for the rotating luer to detach from the dilator hub during use.Use of the affected angiodynamics stiffened micro-introducer kits may result in patient harm, including minor tissue trauma and/or minor delay in procedure to replace the device.
  • Acción
    Medical Specialties Australia have contacted affected customers and retrieved all unused product. This action has been closed-out on 24/05/2017.

Device

4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer) Product Description: STF 4F...
  • Modelo / Serial
    4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer)Product Description: STF 4F M.I. KIT 45CM NT/T ECHO S PGCatalogue Number: 06597052Lot Numbers: 5031722 & 5043440ARTG Number: 172522
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA