Events

Retiro De Equipo (Recall) de INFUSOR

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
    41639
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-06-21
  • 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
    Baxter corporation has initiated a recall for the listed devices due to an increase in complaints for leaks at the distal male luer and luer cap. baxter has resolved the issue and has since implemented enhancements to the blue winged cap to improve the seal between the cap and the luer. complaint rates for leaks have since decreased. baxter wants to ensure that no affected product remains in the field.

Device

INFUSOR
  • Modelo / Serial
    Model Catalog: 2C1075KJP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2C1080KJP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2C1082KJP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2C1073KJP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2C1071KJP (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    COILED TUBE INFUSORS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION