Events

Recall of Nitrous oxide nitrile type B05 bottles

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 Air Products Médical.

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
    2002-10-21
  • 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-certaines-bouteilles-de-type-b05-de-protoxyde-d-azote-pour-cryotherapie-de-la-societe-air-products-medical
  • 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
    Air Products Médical is withdrawing some nitrous oxide nitrile type B05 bottles from the market due to the incompatibility of a dip tube valve with the use of certain cryotherapy devices that could damage them. * These bottles are identifiable as follows: The valves have a blue dot on the valve under the gas outlet, and / or an orange plastic washer located at the base of the faucet under the colored test washer. This information does not apply to nitrous oxide for inhalation Air Products Medical, general anesthesia medication.

Device

Nitrous oxide nitrile type B05 bottles

Manufacturer

Air Products Médical
  • Source
    LAANSM