Events

Retiro De Equipo (Recall) de PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” 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 Allegra Orthopaedics Limited.

¿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-00493-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-21
  • 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-00493-1
  • 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
    Allegra orthopaedics is performing a recall of specific lot numbers of the pf6 tube assembly which is a component of the peripheral vascular infusion/aspiration catheter or “pad” catheter. this is the only component of the pad affected by this recall action as this is the component that is ethylene oxide sterilised.Following a review of the validation of the ethylene oxide sterilisation process for the pf6 tube assembly, it was apparent that there is insufficient evidence to demonstrate that a sterility assurance level (sal) of at least 10-6 was achieved.
  • Acción
    Allegra Orthopaedics is advising users to inspect stock and quarantine any remaining units of the affected devices for return.

Device

PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” c...
  • Modelo / Serial
    PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” catheter)Catalogue Number: 20-000965Lot Number: 15012700Expiry Date: April 2017ARTG Number: 164450
  • Manufacturer
    Allegra Orthopaedics Limited

Manufacturer

Allegra Orthopaedics Limited