Events

Retiro De Equipo (Recall) de FEM-FLEX II VENOUS CANNULA

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por EDWARDS LIFESCIENCES (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
    49930
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-03-26
  • 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
    Through post market surveillance edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula sizes 8 10 and 12 french only. edwards has received one customer complaint regarding a released wire located at the tip area of the cannula which was identified prior to use. although the condition does not affect the functionality of the cannula there is potential patient safety risk if a protruding wire is not detected prior to use.

Device

FEM-FLEX II VENOUS CANNULA
  • Modelo / Serial
    Model Catalog: FEMII012V (Lot serial: 59873252); Model Catalog: FEMII008A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII008V (Lot serial: 59873252); Model Catalog: FEMII012V (Lot serial: 59849124); Model Catalog: FEMII010V (Lot serial: 59849124); Model Catalog: FEMII008V (Lot serial: 59849124); Model Catalog: FEMII012V (Lot serial: 59796683); Model Catalog: FEMII010V (Lot serial: 59796683); Model Catalog: FEMII008V (Lot serial: 59796683); Model Catalog: FEMII012V (Lot serial: 59723307); Model Catalog: FEMII010V (Lot serial: 59723307); Model Catalog: FEMII008V (Lot serial: 59723307); Model Catalog: FEMII012V (Lot serial: 59890924); Model Catalog: FEMII010V (Lot serial: 59890924); Model Catalog: FEMII008V (Lot serial: 59890924); Model Catalog: FEMII012V (Lot serial: 59849119); Model Catalog: FEMII010V (Lot serial: 59849119); Model Catalog: FEMII008V (Lot serial: 59849119); Model Catalog: FEMII012V (Lot serial: 59751074); Model Catalog: FEMII010V (Lot serial: 59751074); Model Catalog: FEMII008V (Lo
  • Descripción del producto
    FEM-FLEX II VENOUS CANNULA
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.