Retiro De Equipo (Recall) de Device Recall Baxter

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 Corporation Englewood.

¿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
    Dispenser, liquid medication - Product Code KYX
  • Causa
    Self-righting luer tip caps were manufactured and shipped with a missing latex symbol on both single and case labels.
  • Acción
    Baxter sent an Safety Alert letter dated January 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1.Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to Returning the customer reply form promptly will prevent you from receiving repeat notices. 2. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. Action to be taken if you are an end-user and purchased product from a distributor or reseller: 1. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. 2. Follow your supplier's reply process. Please do not return the customer reply form to Baxter. Action to be taken if you are a distributor: If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Safety Alert in accordance with your customary procedures. Further information and support For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time.


  • Modelo / Serial
    All DiscPac products are affected within expiry up to October 2017
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.
  • Manufacturer


  • Dirección del fabricante
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Empresa matriz del fabricante (2017)
  • Source