Events

Retiro De Equipo (Recall) de FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAXTER CORPORATION.

¿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
    19685
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-03-16
  • 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
    During an expanded review of records (see also recall number 53158) for the service activities performed by baxter corporation's local technical service centre it was found that required functional tests were potentially not performed on an additional number of colleague single channel and colleague triple channel volumetric infusion pumps.

Device

FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP
  • Modelo / Serial
    Model Catalog: DNM9163L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: DNM9163 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M9163 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M9163L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M9163LU (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163LU (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM8153L (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151KL (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM9161L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: DNM9161 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: DNM8151L (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161L (Lot serial: >1000 NUMBERS CONTACT MFR); Mod
  • Descripción del producto
    FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION