Events

Retiro De Equipo (Recall) de INFUSOR LOW VOLUME

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
    95491
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-09-09
  • 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 initiated important safety information regarding the infusor and intermate portable elastomeric infusion systems. contact manufacturer for a listing of all product codes affected. baxter has received complaints for infusion flow rates greater than intended for the referenced portable elastomeric infusion systems. in many cases the complaint details an overinfusion of medication that is the result of uses inconsistent with the instructions for use.

Device

INFUSOR LOW VOLUME
  • Modelo / Serial
    Model Catalog: 2C1009KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1156KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1008KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1730K (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1734K (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1154KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1955KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1704P (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1702KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1701KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1087KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1063KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1082KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1080KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1075KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1073KJP (Lot serial: > 10 cont
  • Descripción del producto
    INFUSOR LV - Portable Elastomeric Infusion System
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION