Events

Retiro De Equipo (Recall) de BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warming Blanket)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Molnlycke Health Care 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-01087-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-11-13
  • 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-01087-1
  • 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 affected blankets have a shelf life of 3 years but testing has indicated that blankets that are more than two years old, do not warm to the specified level of 10 hours.
  • Acción
    Molnlycke Healthcare is informing customers to inspect their current stock. BARRIER Easywarm/Easywarm+ Products which are less than 2 years old (expiry date minus 1 year) can be used normally up until the 2 year mark. In the event that the customer has any BARRIER Easywarm/Easywarm+ products which are over 2 years old but less than 3 years, the customer is to contact the local Mölnlycke Sales Manager to arrange either a full refund or a replacement at no extra cost. This action has been closed-out on 31/08/2016.

Device

BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warmin...
  • Modelo / Serial
    BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warming Blanket) ARTG Number: 198120
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd