Retiro De Equipo (Recall) de Device Recall NonDEHP Catheter 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
  • Acción
    Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers.


  • Modelo / Serial
    A) Product Code 2N8371: Lots R12E03108, R12H27085, R12H28075, R12H29057, R12H30139, R12103092, R12104058, R12105022, R12106061, R12110113, R12119056, R12120112, R12121151, R12122050, R12124106, R12124130, R12J25045, R12K03057, R12K19046, R12K21034, R12K21083, R12L05118, R12L08054, R12L18111, R12Ll9101, R13A08063, R13A08147, Rl3A09137, R13A10101, R13A14129, R13A15050
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
  • Descripción del producto
    A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only || Product Usage: || The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
  • Manufacturer


  • Dirección del fabricante
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Empresa matriz del fabricante (2017)
  • Source