Events

Retiro De Equipo (Recall) de Pico 70 Arterial Blood sampler

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific 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-01236-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-21
  • 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-2014-RN-01236-1
  • 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
    Radiometer has recently become aware of a potential risk with the pico70 arterial blood sampler, 956-529 of lot lm-052. it has been reported that some needles have a brownish coating. the needle may not be sterile and if contaminated would expose the patient to a risk of developing a blood stream infection.
  • Acción
    Radiometer is requesting their customers to quarantine stock from lot 956-529LM52. Radiometer will arrange for the collection of the affected product. This action has been closed-out on 01/03/2016.

Device

Pico 70 Arterial Blood sampler
  • Modelo / Serial
    Pico 70 Arterial Blood samplerLot number: 956-529LM52ARTG number: 135319
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd