Events

Retiro De Equipo (Recall) de 300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por KCI 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-01169-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-02
  • 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-2015-RN-01169-1
  • 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
    Internal testing has revealed the potential for small holes the size of a pin to develop in the pouches of the sterile canisters. if these small holes occur and the canister is used in a sterile field, there is a potential for contamination.To date, there have been no complaints regarding damaged packaging or reports of any patient injuries or complications due to potentially non-sterile canisters.
  • Acción
    The sponsor is advising the users to inspect stock and quarantine the affected units prior to their return. Alternatively, users can continue to use the affected devices provided that the tubing cap remains in the tubing until use and the canister is used outside of the operating room's sterile field. This action has been closed-out on 26/08/2016.

Device

300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System
  • Modelo / Serial
    300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System Part number M8275059/5Lot Numbers: 2590876 (expiry date 11/2016) and 2590877 (expiry date 01/2017) ARTG Number: 226774
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd