Events

Retiro De Equipo (Recall) de Arterial and venous femoral cannula lot removal with armature

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 Sorin Group Italia Srl.

¿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
    2007-10-02
  • 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-de-canules-femorales-arterielles-et-veineuses-en-polyurethane-avec-armature-societe-sorin-group-france
  • 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 October 1, 2007, Sorin Group France withdrew from the market the batches of the references contained in the attached message of the medical device called veinous and arterial femoral cannulae made of polyurethane with reinforcement, including pediatric models, manufactured by Sorin Group Italia Srl, following an incident report mentioning the breakage of the tip of the introducer guide during the introduction of the cannula at the site of cannulation. The company Sorin Group France has directly notified the recipients of the incriminated lots with the message attached (02/10/2007) (34 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Arterial and venous femoral cannula lot removal with armature

Manufacturer

Sorin Group Italia Srl