Events

Retiro De Equipo (Recall) de Crepe Bandage 5cm x 1.5m

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Linear Medical 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-2014-RN-00688-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-27
  • 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-2014-RN-00688-1
  • 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
    Testing by therapeutic goods administration (tga) has identified sterility failure for the batch number: 050713hf. samples tested by the tga have identified the presence of bacillus pumilus. the use of contaminated bandage is a potential safety concern especially when used on open wounds. no other batches of crepe bandages are supplied in australia.
  • Acción
    If customers are holding the affected batch number, please discard any single units and unopened cartons should be returned to Clifford Hallam for full credit. This action has been closed-out on 18/02/2016.

Device

Crepe Bandage 5cm x 1.5m
  • Modelo / Serial
    Crepe Bandage 5cm x 1.5mBatch Number: 050713HFARTG Number: 213908
  • Manufacturer
    Linear Medical Pty Ltd

Manufacturer

Linear Medical Pty Ltd