Events

Retiro De Equipo (Recall) de GOLDBALLOON DETACHABLE BALLOONS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por YOCAN MEDICAL SYSTEMS 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
    119830
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-09-07
  • 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
    A defect has been identified by the manufacturer that when fitting the balloon onto the needle for bench testing prior to its use the tightening of the balloon valve was insufficient.

Device

GOLDBALLOON DETACHABLE BALLOONS
  • Modelo / Serial
    Model Catalog: GOLDBAL 3 (Lot serial: 20040301); Model Catalog: GOLDBAL 2 (Lot serial: 20040104); Model Catalog: GOLDBAL 3 (Lot serial: 20040104); Model Catalog: GOLDBAL 4 (Lot serial: 20040104); Model Catalog: GOLDBAL 1 (Lot serial: 20040401); Model Catalog: GOLDBAL 4 (Lot serial: 20040401); Model Catalog: GOLDBAL 3 (Lot serial: 20040401); Model Catalog: GOLDBAL 2 (Lot serial: 20040401); Model Catalog: GOLDBAL 1 (Lot serial: 20040302); Model Catalog: GOLDBAL 4 (Lot serial: 20040302); Model Catalog: GOLDBAL 3 (Lot serial: 20040302); Model Catalog: GOLDBAL 2 (Lot serial: 20040302); Model Catalog: GOLDBAL 1 (Lot serial: 20040301); Model Catalog: GOLDBAL 4 (Lot serial: 20040301); Model Catalog: GOLDBAL 2 (Lot serial: 20040301); Model Catalog: GOLDBAL 1 (Lot serial: 20040101); Model Catalog: GOLDBAL 4 (Lot serial: 20040101); Model Catalog: GOLDBAL 3 (Lot serial: 20040101); Model Catalog: GOLDBAL 2 (Lot serial: 20040101); Model Catalog: GOLDBAL 1 (Lot serial: 20031202); Model Catalog: GOLDBAL 4 (Lot serial: 20031
  • Descripción del producto
    GOLDBAL DETACHABLE BALLOON
  • Manufacturer
    YOCAN MEDICAL SYSTEMS INC.

Manufacturer

YOCAN MEDICAL SYSTEMS INC.