Events

Retiro De Equipo (Recall) de Device Recall Baxter Solution Set with DuoVent Spike

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
    Recall
  • ID del evento
    59419
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2920-2011
  • Fecha de inicio del evento
    2011-07-21
  • Fecha de publicación del evento
    2011-08-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102723
  • 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
    Intravascular Administration Set - Product Code FPA
  • Causa
    The solution sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. the reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.
  • Acción
    Baxter Healthcare Corporation sent a "Urgent Product Recall" letter dated July 21, 2011 to all affected customers. The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers. For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Device Recall Baxter Solution Set with DuoVent Spike
  • Modelo / Serial
    Product Code 1C8507s, lot numbers GR291542, GR292409, GR292797 and GR294454.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    (USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.
  • Descripción del producto
    Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. || Baxter Healthcare Corporation. || A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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