Events

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

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Atricure Inc.

¿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
    17831
  • Fecha de inicio del evento
    2014-12-04
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: N Stenning & Co NZ Limited, C/O Bellingham Wallace, 470 Parnell Road, Parnell, Auckland 1052
  • 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
    Product to be returned to supplier

Device

AtriCure CryoICE cryo-ablation probe
  • Modelo / Serial
    Model: Model: CRY02, Affected: Lot Numbers: 26500 through to 53607
  • Manufacturer
    Atricure Inc

Manufacturer

Atricure Inc