Events

Retiro De Equipo (Recall) de ClaveGuard Diathermy Pencil

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ClaveGuard 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-2016-RN-00280-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-11
  • 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-2016-RN-00280-2
  • 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
    Claveguard has been advised that diathermy pencils manufactured under batch number 181214sy have an issue with the quality of the ink used for the sterility check mark, which may compromise the ability to clearly discern the colour change. as a precautionary measure, claveguard is recalling the affected batch.
  • Acción
    The sponsor ClaveGuard advises customers to discontinue use of any remaining stock of the affected batch prior to their quarantine. The sponsor will arrange for the replacement and recovery of the affected units. This action has been closed-out on 16/02/2017.

Device

ClaveGuard Diathermy Pencil
  • Modelo / Serial
    ClaveGuard Diathermy PencilBatch Number: 18214SYARTG Number: 222138
  • Manufacturer
    ClaveGuard Pty Ltd

Manufacturer

ClaveGuard Pty Ltd
  • Source
    DHTGA