Events

Retiro De Equipo (Recall) de Device Recall Container, IV

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 Baxa Corporation.

¿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
    58304
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1964-2011
  • Fecha de inicio del evento
    2011-03-08
  • Fecha de publicación del evento
    2011-04-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99077
  • 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, i.V. Fluid transfer - Product Code LHI
  • Causa
    Tpn bags may leak during filling operation, due to bag manufacturing error.
  • Acción
    The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.

Device

Device Recall Container, IV
  • Modelo / Serial
    All codes sold since 7/23/2009.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, Venezuela.
  • Descripción del producto
    ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. || A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • Dirección del fabricante
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA