Events

Retiro De Equipo (Recall) de Dual Luer Lock Cap

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
    66249
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0143-2014
  • Fecha de inicio del evento
    2013-09-10
  • Fecha de publicación del evento
    2013-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121842
  • 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
    Port, protector/cushion - Product Code OBK
  • Causa
    The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. particulate matter entering the fluid path from the luer lock caps may result in embolic events.
  • Acción
    Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to : 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use.The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and returning it to Baxter by either faxing it to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 1-888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. Please have the product code and lot number(s) available. 4.If you are a dealer, wholesaler,or distributor/reseller that distributed any product to other facilities, please forward this communication. Baxter distributed this product to customers between June 19, 2013 and August 20, 2013. The Center for One Baxter is available at 1-800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.

Device

Dual Luer Lock Cap
  • Modelo / Serial
    10043, 10044
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the country of Canada.
  • Descripción del producto
    Dual Luer Lock Cap || The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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