Events

Retiro De Equipo (Recall) de ContinuFlo Solution Set with Large Bore 4Way Stopcock Extension Set

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
    31800
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0943-05
  • Fecha de inicio del evento
    2005-04-21
  • Fecha de publicación del evento
    2005-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38524
  • 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
    Stopcock, I.V. Set - Product Code FMG
  • Causa
    There is an unsecure connection between the male luer and the stopcock on the i.V. extension set.
  • Acción
    Recall letters dated 4/21/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Materials Management. The accounts were informed of the reports of an unsecure connection between the male luer and the stopcock due to silicone on the male luer tip, and were requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit.

Device

ContinuFlo Solution Set with Large Bore 4Way Stopcock Extension Set
  • Modelo / Serial
    product code 3C0062s, lot numbers R04D28173, R04D28181, R04D28199, R04F22288, R04F23237, R04F25273, R04G24100, R04G26071, R04H12020, R04H13085, R04H13242, R04H30303, R04I21151, R04J06227, R04J07076, R04J07092, R04J28122, R04K08064, R04K08221, R04K26090, R04K29086, R04L09110, R04L17055, R04L17188, R04L18137, R05A20092, R05A20217, R05B03187, R05B04060, R05B28192
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and internationally to American Samoa and Venezuela.
  • Descripción del producto
    Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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