Events

Retiro De Equipo (Recall) de Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal mask airway 2 Large paediatric, wire-reinforced laryngeal mask airway 2.5 Small adult, wire-reinforced laryngeal mask airway 3 Medium adult, wire-reinforced laryngeal mask airway 4 Large adult, wire-reinforced laryngeal mask airway

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Intersurgical 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-00447-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-04-05
  • 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-2017-RN-00447-1
  • 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
    An internal assessment by intersurgical of product performance, including a review of customer complaints, has confirmed that specific solus flexible wire-reinforced laryngeal mask airway products have a manufacturing fault in the tube. this fault can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient.
  • Acción
    Intersurgical is advising users to inspect their stocks and quarantine all units from the affected lot numbers, and to destroy these affected products. Credit will be arranged for this stock.

Device

Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal...
  • Modelo / Serial
    Solus Flexible, wire-reinforced laryngeal mask airwaySmall paediatric, wire-reinforced laryngeal mask airway 2Large paediatric, wire-reinforced laryngeal mask airway 2.5Small adult, wire-reinforced laryngeal mask airway 3Medium adult, wire-reinforced laryngeal mask airway 4Large adult, wire-reinforced laryngeal mask airway 5Order Codes: 8002001, 8025001, 8003001, 8004001, 8005001Lot Numbers: from 31310354 to 31700331ARTG Number: 224554
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd