Events

Retiro De Equipo (Recall) de AtriCure CryoICE cryo-ablation probe (CRYO2)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por N Stenning & Co 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-01258-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-28
  • 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-01258-1
  • 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
    This recall has been initiated due to a packaging defect that could potentially compromise the sterility of this device. use of a non-sterile device could potentially cause permanent impairment or life-threatening injury. no injuries or deaths have been reported.
  • Acción
    Hospitals are requested immediately quarantine and return all affected stock to the Australian distributor, N Stenning & Co. This action has been closed-out on 04/08/2016.

Device

AtriCure CryoICE cryo-ablation probe (CRYO2)

Manufacturer

N Stenning & Co Pty Ltd