Events

Rappel de OXALYS oxygen cylinders with an integrated valve regulator V2D15 version F

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par SOL France.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2009-06-23
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-bouteilles-d-oxygene-medicinal-oxalys-de-la-societe-sol-france
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    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

OXALYS oxygen cylinders with an integrated valve regulator V2D15 version F
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    SOL France

Manufacturer

SOL France
  • Source
    LAANSM