Events

Retiro De Equipo (Recall) de Infusor SV2 and syringe

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
    2009-03-10
  • 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-lot-infusor-sv2-et-seringue-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
    On March 6, 2009, the company BAXTER withdrew from the market the 2008K21 batch of the reference 2C1702KD of the medical device called "Infusor SV2 and syringe" following an error on the refund sticker. The sticker corresponds, in fact, to the product "Intermate SV100" instead of "Infusor SV2". The product concerned, apart from the error on the sticker, complies with the product specifications. The BAXTER company has directly notified the distributors of the offending lot who will inform the recipients concerned with the enclosed message (10/03/2009) (30 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. Given the small number of recipients, no alert number has been assigned to this withdrawal.

Device

Infusor SV2 and syringe
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER