Retiro De Equipo (Recall) de Device Recall Baxter Interlink System Large Bore 4Way Stopcock

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
    58834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2623-2011
  • Fecha de inicio del evento
    2011-05-17
  • Fecha de publicación del evento
    2011-06-22
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-06-18
  • Fuente del evento
    USFDA
  • 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
    intravascular set - Product Code FMG
  • Causa
    There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product.
  • Acción
    Baxter Urgent Product Recall letters dated May 17, 2011 were mailed via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, on the same date, informing them that potential pinholes and tears in the individual packaging could compromise the sterility of the stopcock. The accounts were requested to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also requested to 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 can 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. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 5/17/11, and instructed to notify their customers and ministries of health of the recall.

Device

  • Modelo / Serial
    product code 2N5601, lot number UR08C31068
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    California and internationally to Japan and Australia
  • Descripción del producto
    Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer

Manufacturer

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