Retiro De Equipo (Recall) de Ultrasound Probe Cover (Telescopic folded with gel); and All Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Meditech Systems Asia 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-2017-RN-00631-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-05-12
  • 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
    Meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia. whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd.Are also affected by this recall.
  • Acción
    All product labelled Meditech and Manufactured by Yafho Bio-Technology Co Ltd and/or Linmed Medical Co Ltd, including all stock of UltraSound Probe Cover (Telescopic folded with gel), is being quarantined immediately and Recalled from the Market. For further information please see https://www.tga.gov.au/alert/meditech-ultrasound-gel .

Device

  • Modelo / Serial
    Ultrasound Probe Cover (Telescopic folded with gel); andAll Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.Part Number/ Order Code: 88654012Lot Number: 201701ARTG Number: 278197
  • Manufacturer

Manufacturer