Events

Retiro De Equipo (Recall) de 30-40 MM/HG ABOVE KNEE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AIRWAY SURGICAL APPLIANCES 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
    63248
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-12-07
  • 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
    This recall has been initiated due to 'pressure percentage proximal decrease not being within the optimal range specified for specific styles. when the product is out of range for pressure percentage it may not effectively manage poor circulation in the lower extremity as intended. this may only have an effect on a small percentage of the population.

Device

30-40 MM/HG ABOVE KNEE
  • Modelo / Serial
    Model Catalog: 8848BG-XL (Lot serial: ); Model Catalog: 846-S (Lot serial: ); Model Catalog: 8848BL-XL (Lot serial: ); Model Catalog: 8848BL-L (Lot serial: ); Model Catalog: 8848BG-L (Lot serial: ); Model Catalog: 8848BG-M (Lot serial: ); Model Catalog: 8848BG-S (Lot serial: ); Model Catalog: 8846-M (Lot serial: ); Model Catalog: 8846-S (Lot serial: ); Model Catalog: 848BG-XL (Lot serial: ); Model Catalog: 848BG-L (Lot serial: ); Model Catalog: 848BG-M (Lot serial: ); Model Catalog: 846-XL (Lot serial: ); Model Catalog: 846-L (Lot serial: ); Model Catalog: 846-M (Lot serial: ); Model Catalog: 865-3L (Lot serial: ); Model Catalog: 865-2L (Lot serial: ); Model Catalog: 865-XL (Lot serial: ); Model Catalog: 865-M (Lot serial: ); Model Catalog: 865-S (Lot serial: ); Model Catalog: 864BG-2L (Lot serial: ); Model Catalog: 864BG-XL (Lot serial: ); Model Catalog: 864BG-L (Lot serial: ); Model Catalog: 864BG-M (Lot serial: ); Model Catalog: 864BG-S (Lot serial: ); Model Catalog: 8868BL-L (Lot serial: ); Model Catalog
  • Descripción del producto
    30-40 MM/HG ABOVE KNEE
  • Manufacturer
    AIRWAY SURGICAL APPLIANCES LTD.

Manufacturer

AIRWAY SURGICAL APPLIANCES LTD.