Retiro De Equipo (Recall) de OXALYS oxygen cylinders with an integrated valve regulator V2D15 version F

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 SOL 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
    2009-06-23
  • 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
    Since 19 June 2009, SOL France has been withdrawing OXALYS oxygen cylinders with an integrated valve regulator V2D15 version F, following a new "gunshot" accident that occurred on its premises. during a check after filling the bottle. Although at this stage the pressure regulator can not be formally identified as a cause of the gunshot, as a precautionary measure, a recall of all OXALYS oxygen cylinders with this type of F pressure regulating valve has been implemented at users concerned, including health facilities, pharmacies and home oxygen dispensing facilities. The withdrawal is accompanied by the progressive replacement of OXALYS oxygen cylinders with built-in faucet type V2D15 version F. Users will receive a letter from the company SOL giving them the number of bottles concerned and how to replace them. Patients holding oxygen cylinders of this type at home will be contacted by the facility that provided them. Read also:. press release of 23 June 2009: Accident of "gunshot" following the filling of an oxygen cylinder for medical use

Device

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM