Retiro De Equipo (Recall) de Colleague Mono, CX and CXE Volumetric Infusion Pumps

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Baxter Healthcare Corp..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    infusion pump - Product Code FRN
  • Causa
    The fda sent a letter to baxter on april 30, 2010, ordering the company to recall and destroy all models of its colleague volumetric infusion pumps currently in use in the united states. fda determined that this action is necessary, as baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the colleague pumps still in use. this recall is a consolidation of al.
  • Acción
    Baxter Healthcare Corporation sent "Urgent Product Recall" letters dated August 4, 2010 to all Colleague Infusion Pump customers in the U.S., to the attention of the Hospital Administrator, Chief Executive Officer, Chief Operating Officer, Chief Medical Officer and Chief Nursing Officer, referencing Baxter's May 3, 2010 announcement to recall all Colleague pumps from the U.S. market pursuant to an order under its existing consent decree with the FDA. The letters provided the customers with important information regarding the actions they must take prior to November 14, 2010 in order to continue using their Colleague pumps during the transition period. Customers were instructed to complete the attached Certificate of Medical Necessity Form and return it to Baxter as soon as possible, but no later than November 14, 2010, by scanning and e-mailing to Baxter at Any questions were directed to their local Baxter Sales Representative or by calling the Center for One Baxter 1-800-422-9837, between 8AM and 5 PM Central Standard Time (CST). *** On July 20, 2011 Baxter sent recall letters to those Colleague customers who had not completed a decision form regarding the status and replacement of their Colleague Pumps. The accounts were asked to inform their Baxter sales representative as soon as possible of their pump decision, and to complete the attached customer reply form and return it to Baxter via fax or scanned e-mail. ***


  • Modelo / Serial
    All product numbers and all serial numbers sold in the U.S.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide, including Puerto Rico
  • Descripción del producto
    Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
  • Manufacturer


  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source