Events

Retiro De Equipo (Recall) de Baxter NonDEHP I.V. Catheter TConnector 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
    56718
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0157-2011
  • Fecha de inicio del evento
    2010-09-09
  • Fecha de publicación del evento
    2010-10-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94356
  • 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
    During packaging testing, baxter observed tears and pinholes in chevron-style pouches for certain infusion disposable products. the pinholes and tears could compromise the sterile barrier properties of the pouch.
  • Acción
    Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Baxter NonDEHP I.V. Catheter TConnector Extension Set
  • Modelo / Serial
    product 2N9057, lots UE104968, UE105502, UE106096, UE106369, UE106971, UE107029, UE107276, UE107318, UE107664, UE107672, UE107706, UE112565, UE112953, UE113118, UE113134, UE113258, UE103440, UE103457 and UE103465
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
  • Descripción del producto
    Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9057 || For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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