Events

Retiro De Equipo (Recall) de DUOFLO

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
    2002-03-20
  • 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-d-un-lot-de-dm-duoflo-de-la-societe-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 BAXTER company withdraws from the market lot 05290106 the topical / surgical manual vaporizer medical device reference B2232000999999 following a signal of detachment of the spray nozzle of this device during its use and the potential risk for the patient in case this separation occur during a surgical procedure, since the spray tip is not radiopaque. This device is used for the application of fibrin glue .. Description of the incident: risk of detachment of the spray tip of this device during its use .. Consequences or risk: risk of loss of the tip at the level of the wound because it is not radiopaque .. Given the reduced number of recipients of this lot, they were warned directly by the laboratory .. Therefore, no alert number n 'has attributed to this withdrawal.

Device

DUOFLO
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER