Retiro De Equipo (Recall) de Specialties range Physiologica, 0.9% sodium chloride, Lyomer and saline

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 Gifrer Barbezat.

¿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
    2013-04-26
  • País del evento
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
  • 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
    At the request of the ANSM, Gifrer Barbezat laboratories proceed, as a precautionary measure, to the recall, to their places of distribution, of certain batches of the medical devices listed below. This recall follows the detection of regulatory nonconformities in the manufacture of these medical devices that can not guarantee the quality of these products. The products concerned by this recall are. Physiologica Small child physiological serum 20 single dose / 5 m. Physiologica Small child physiological serum 40 single dose / 5 m. Physiologica Small child physiological serum 60 single dose / 5 m. Sodium Chloride 0.9% 30 vials / 100 m. Sodium Chloride 0.9% 30 vials / 45 m. Lyomer infant nasal spray solution 100 m. Lyomer plus nasal spray solution 100 m. Lyomer plus nasal spray solution 40 m. Lyomer nasal solution spray 100 m. SeptiLyomer nasal spray solution 40m. Physiological serum plus pharmacy 30 single doses / 5 m. Viaref physiological serum 30 single doses / 5 m. Physiologica dermactive 60 single doses / 5 m. Read auss. Decision of 22/04/2013 suspending the manufacture, placing on the market, export and distribution of medical devices, listed in the appendix, placed on the market by the company GIFRER BARBEZAT and the company LBD and withdrawing certain lots of these products. Courrier des laboratoires Gifrer Barbezat informing the batch recall (26/04/2013) (65 ko)

Device

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM