Events

Retiro De Equipo (Recall) de COLLEAGUE GUARDIAN ENHANCED CXE COLOR 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
    23457
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-02-13
  • 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
    During a review of records for the service activities performed by baxter corporation's local test service it was identified that required functional tests were potentially not performed on the identified colleague volumetric infusion pumps.

Device

COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
  • Modelo / Serial
    Model Catalog: 2M9161 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2M9161L (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2M8153 (Lot serial: 11100952CT); Model Catalog: 2M8161 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: DMN 8151 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2M8161LU (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: DNM9161 (Lot serial: 18010089JF); Model Catalog: DNM9161L (Lot serial: 18010089JF); Model Catalog: DNM9161 (Lot serial: 18020088JF); Model Catalog: DNM9161L (Lot serial: 18020088JF); Model Catalog: DNM9161 (Lot serial: 17060477JF); Model Catalog: DNM9161L (Lot serial: 17060477JF); Model Catalog: DNM9161 (Lot serial: 17080209JF); Model Catalog: 2M8163LU (Lot serial: 15010161TC); Model Catalog: DNM 8153 (Lot serial: 15010161TC); Model Catalog: 2M8163 (Lot serial: 15010161TC); Model Catalog: 2M8153 (Lot serial: 15010161TC); Model Catalog: 2M8163LU (Lot serial: 15010004TC); Model Catalog: DNM 8153 (Lot serial: 15010004TC); Model Catalog: 2M8163 (
  • Descripción del producto
    COLLEAGUE GUARDIAN CXE COLOR PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION