Events

Retiro De Equipo (Recall) de Sterile urine collectors

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 CONVATEC / UNOMEDICAL.

¿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
    2010-12-23
  • 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/collecteurs-a-urine-steriles-societe-convatec-unomedical-rappel-de-lots
  • 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
    In agreement with Afssaps, the company Convatec / Unomedical, on 20/12/10, recalled some batches (23/12/2010) (13 ko) of urine collectors. The health establishments (23/12/2010) (62 ko) (directors of institutions, local correspondents of materiovigilance and pharmacists) and the distributors (23/12/2010) (90 ko) concerned received the enclosed letters. . A letter sent to patients at home (23/12/2010) (61 KB) was also sent to the distributors. The competent European authorities were informed of this measure by the manufacturer. This information is addressed to the directors, local correspondents of materiovigilance and pharmacists of the health establishments for diffusion to the concerned services, as well as to the distributors and the patients.

Device

Sterile urine collectors

Manufacturer

CONVATEC / UNOMEDICAL