Events

Retiro De Equipo (Recall) de Transradial Artery Access Kits

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mayo Healthcare 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-2013-RN-01087-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-22
  • 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-2013-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 manufacturer has advised that this action is due to a foreseen risk that the introducer needles packaged within the kits can be partially or fully occluded. if an occluded needle is used on a patient, there is risk of delay in treatment and/or adverse event requiring medical intervention.
  • Acción
    Customers are asked to quarantine any affected stock. Mayo Healthcare customer service will contact customers with affected stock to arrange return, dispatch of replacement stock, or issuance of a credit note.

Device

Transradial Artery Access Kits
  • Modelo / Serial
    Transradial Artery Access Kits Product Codes: AA106111, AA15511-S, AA15611-SMultiple serial numbersARTG Number: 135922
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd