Events

Retiro De Equipo (Recall) de VITAL-PORT MRI PETITE VASCULAR ACCESS PORT (SINGLE CHAMBER) - POLYSULFONE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COOK (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
    23378
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-13
  • 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
    The non-coring needle included with the sets has the potential to dislodge silicone from the septum of the port component. hypothetically this could lead to embolization of a fragment or leakage of medication/injectable fluids into surrounding tissues. neither of these potential consequences has been reported.

Device

VITAL-PORT MRI PETITE VASCULAR ACCESS PORT (SINGLE CHAMBER) - POLYSULFONE
  • Modelo / Serial
    Model Catalog: IP-S6118 (Lot serial: >10 contact mfr); Model Catalog: IP-S6110 (Lot serial: >10 contact mfr); Model Catalog: IP-S6113 (Lot serial: >10 contact mfr); Model Catalog: IP-S6118-MPIS-NT (Lot serial: >10 contact mfr); Model Catalog: IP-S5118 (Lot serial: >10 contact mfr); Model Catalog: IP-S7029 (Lot serial: >10 contact mfr); Model Catalog: IP-S7129 (Lot serial: >10 contact mfr); Model Catalog: IP-7112 (Lot serial: >10 contact mfr); Model Catalog: IP-9112 (Lot serial: >10 contact mfr); Model Catalog: IP-S6112 (Lot serial: >10 contact mfr); Model Catalog: IP-S7112 (Lot serial: >10 contact mfr); Model Catalog: IP-S9012 (Lot serial: >10 contact mfr); Model Catalog: IP-S9112 (Lot serial: >10 contact mfr); Model Catalog: IP-7110 (Lot serial: >10 contact mfr); Model Catalog: IP-S7010 (Lot serial: >10 contact mfr); Model Catalog: IP-S7110 (Lot serial: >10 contact mfr); Model Catalog: IP-S9010 (Lot serial: >10 contact mfr); Model Catalog: IP-S9110 (Lot serial: >10 contact mfr); Model Catalog: IP-S6010 (Lot
  • Descripción del producto
    VITAL-PORT MRI PETITE VASCULAR ACCESS;VITAL-PORT VASCULAR ACCESS PORT;VITAL-PORT PETITE VASCULAR ACCESS PORT;VITAL-PORT PETITE DUAL LUMEN VASCULAR ACCESS;VITAL-PORT MRI VASCULAR ACCESS SYSTEM PORT;VITAL-PORT MINI VASCULAR ACCESS
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.