Retiro De Equipo (Recall) de Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7') Oxygen Tubing

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConvaTec 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-2017-RN-00649-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-26
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    An internal assessment of product reports by convatec has confirmed that specific high concentration oxygen masks have an issue whereby the tubing has been found to disconnect from the oxygen mask, prior to use or during use, causing a disruption in supply of oxygen.
  • Acción
    ConvaTec is requesting that customers quarantine affected product in their inventory. ConvaTec will organise for product returns and credit.

Device

  • Modelo / Serial
    Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7') Oxygen TubingProduct Code: 108MMBatch Numbers: 106253 and 112025Non-Rebreather Oxygen Mask, Paediatric High Concentration with 2.1 m (7') Oxygen TubingProduct Code: 3230MMBatch Number: 13-20ARTG Number: 189280
  • Manufacturer

Manufacturer