Events

Retiro De Equipo (Recall) de Renu Multiplus, multifunctional solution and Renu MPS

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 Chauvin and Bausch and Lomb France.

¿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
    2010-12-17
  • 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/renu-multiplus-solution-multifonctions-et-renu-mps-solution-multifonctions-chauvin-et-bausch-and-lomb-france-retrait-de-lots2
  • 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 16/12/2010, the company CHAUVIN and the company BAUSCH and LOMB France removed from the market, as a precautionary measure, the batches of the references listed in the appendix (17/12/2010) (18 ko), of the medical device named RENU MPS, multifunctional solution manufactured by Bausch & Lomb IOM (Italy), following observation during routine tests, of results close to the lower limit, on the preservative content, which may suggest that these batches do not be more compliant with all expired specifications. No adverse effects have been reported to the laboratory. This information is addressed to directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned as well as to pharmacists and opticians. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Renu Multiplus, multifunctional solution and Renu MPS

Manufacturer

Chauvin and Bausch and Lomb France