Events

Retiro De Equipo (Recall) de Delivery Tubing for 6060 / Baxter Infusion Pump

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por BAXTER.

¿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
  • Fecha
    2004-12-06
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-tubulures-d-administration-pour-pompe-de-perfusion-6060-baxter
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    The company Baxter has withdrawn from the market on December 3, 2004, the references and batches specified in the appendix, the medical device called "infusion pump administration tubing 6060 with Autoclamp device" following the risk of free flow related to the absence of a cylindrical piece on the cassette, which prevents the pump from clogging the tubing and may result in drug overdose. No case has been reported in Europe .. The company has directly notified the recipients of references and offending batches using the message attached (03/12/2004) (29 KB) validated by Afssaps. This information is addressed to the directors of establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the departments concerned .. The relevant European Competent Authorities are informed of this measure by the manufacturer. References and offending lots (03/12/2004) (29 ko)

Device

Delivery Tubing for 6060 / Baxter Infusion Pump
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER