Events

Retiro De Equipo (Recall) de PARAGON OXYGENATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CHALICE MEDICAL LIMITED.

¿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
    143206
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-09-14
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Due to the coating used on the paragon oxygenators the classification originally assigned to the oxygenators (class ii) is to be amended to a class iv. until the class iv application had been processed manufacturer would voluntarily cease sale of the paragon oxygenators. this does not affect products that have already been sold to customers.

Device

PARAGON OXYGENATOR
  • Modelo / Serial
    Model Catalog: XAMOP***PMP (Lot serial: All Lots); Model Catalog: XAMOPI***MN (Lot serial: All Lots); Model Catalog: XAMOP***PP (Lot serial: All Lots); Model Catalog: XAMOP***MN (Lot serial: All Lots); Model Catalog: XCMOPI140MN (Lot serial: All Lots); Model Catalog: XAMOPI***PMP (Lot serial: All Lots); Model Catalog: XCMOP145PMP (Lot serial: All Lots); Model Catalog: XCMOP43PMP (Lot serial: All Lots); Model Catalog: XAMOPI***PP (Lot serial: All Lots)
  • Descripción del producto
    PARAGON OXYGENATOR;PARAGON INFANT MICRONET INTEGRATED OXYGENATOR;PARAGON INFANT PMP OXYGENATOR;PARAGON NEONATAL PMP OXYGENATOR
  • Manufacturer
    CHALICE MEDICAL LIMITED

Manufacturer

CHALICE MEDICAL LIMITED