Retiro De Equipo (Recall) de Baxter 2B8013 Empty INTRA VIA Container with PVC Ports

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
    69181
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0085-2015
  • Fecha de inicio del evento
    2014-09-16
  • Fecha de publicación del evento
    2014-10-31
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-06-21
  • 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
    Container, i.V. - Product Code KPE
  • Causa
    Particulate matter found inside the fluid path.
  • Acción
    Baxter issued a letter to their consignees stating the following: Baxter is requesting that you take the following actions: Action to be taken if product was purchased directly from Baxter. 1. Locate and remove all affected product from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 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. 3. Complete the enclosed customer reply form , and return it to Baxter by either tax or scanned e-mail. 4. If you distributed any of the affected products to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed product 2B8011 lot U R 13D 15112 to customers between 4/26/2013 and 6/20/2013. Baxter distributed product 2B8013 lot UR13K1 4095 to customers between 11 /27/2013 and 3/ 10/2014. Action to be taken if product was received from an alternate source. 1. Locate and remove all of the affected products from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229- 0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.

Device

  • Modelo / Serial
    Product code 2B8013 Lot Number: UR13K14095
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including Puerto Rico, and the country of Canada.
  • Descripción del producto
    Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories || The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
  • Manufacturer

Manufacturer

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