Events

Retiro De Equipo (Recall) de SAXX STENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BARD CANADA 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
    60523
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2006-11-30
  • 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
    Manufacturer does not hold a valid iso certificate and therefore decided to recall these devices.

Device

SAXX STENT
  • Modelo / Serial
    Model Catalog: PX-S17 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-S10 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M80 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M40 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M13 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M30 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-M20 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L80 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L60 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L40 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L30 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PX-L20 (Lot serial: BETWEEN X0508200 AND X0622400); Model Catalog: PSS15-6-120 (Lot serial: BETWEEN P0508200 AND P0622400); Model Catalog: PSS15-5-120 (Lot serial: BETWEEN P0508200 AND P0622400); Model Catalog: PSS15-6-75 (Lot serial: BETWEEN P0508200 AND P0622400); Mode
  • Descripción del producto
    SAXX PERIPHERAL STENT
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.