Events

Retiro De Equipo (Recall) de Hemodialysis accessories reference S660C and C330 from the company GAMBRO

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 GAMBRO.

¿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
    2003-02-10
  • 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-lots-d-accessoires-pour-hemodialyse-reference-s660c-et-c330-de-la-societe-gambro
  • 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
    GAMBRO withdraws from the market batches 0241-40 and 0238-40 of the reference S660C (product code 6431233A) and batches 0239-40, 0242-40 and 0245-40 of the reference C330 (product code 6430086) of the medical devices called hemodialysis accessories due to a high rate of nonconformities, ie cracks or breaks in the female luer lock connector that can lead to leakage during use (the cases reported to date have not had any serious consequences Patients) .. The S660C is a dialysis accessory that allows the connection between the blood line and the fistula needle or catheter to perform a single needle treatment.The C330 is an extension line for recirculation of the priming solution in the blood lines.

Device

Hemodialysis accessories reference S660C and C330 from the company GAMBRO
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    GAMBRO

Manufacturer

GAMBRO
  • Source
    LAANSM