Events

Retiro De Equipo (Recall) de EASYPUMP LT 100-48;EASYPUMP LT 60-24

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 B.Braun Medical.

¿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
    2008-08-22
  • 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/rappel-de-lots-de-systeme-de-perfusion-easypump-lt-100-48-et-lt-60-24-b-braun-medical
  • 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    On 20/08/2008, the company B.Braun Medical has withdrawn from the market the batches and references mentioned in the recall of the medical devices called: EASYPUMP LT 100-48 and EASYPUMP LT 60-24, the syringes are manufactured by B. Braun Melsungen AG, Switzerland and Easypump infusion sets by I-Flow Corporation in the USA. This withdrawal follows the discovery during a routine inspection of products from the production sample library. perforations of certain syringe packages that may compromise the sterility of the medical device. The company B.Braun medical has directly notified the recipients of the incriminated lots with the message attached (22/08/2008) (193 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

EASYPUMP LT 100-48;EASYPUMP LT 60-24
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    B.Braun Medical

Manufacturer

B.Braun Medical