Events

Recall of OXALYS oxygen cylinders with an integrated valve regulator V2D15 version F

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by SOL France.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2009-06-23
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the data
  • 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
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SOL France

Manufacturer

SOL France
  • Source
    LAANSM