Events

Recall of Single Use Breathing Circuit with Flow Sensor for OSIRIS3 Emergency Ventilator

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 Liquide Medical Systems SA.

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
    2011-02-22
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/circuit-respiratoire-usage-unique-avec-capteur-de-debit-pour-ventilateur-d-urgence-osiris3-air-liquide-medical-systems-s-a--rappel-de-lot
  • 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    Air Liquide Medical Systems SA has withdrawn batches 101151977 and 110152448 from the reference KG020000 of the medical device called: Single-use breathing circuit with flow sensor for emergency ventilator OSIRIS3, manufactured by Flexicare (UK). Indeed, the two lots concerned were equipped with the wrong reference flow sensor. The flow measurement performed is reduced. This induces errors on the measurement of the expired volume of the order of 20% (lower volume). . Air Liquide Medical Systems SA has directly notified the recipients of the incriminated lots by means of the message attached (22/02/2011) (35 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities will be informed of this measure by the manufacturer.

Device

Single Use Breathing Circuit with Flow Sensor for OSIRIS3 Emergency Ventilator

Manufacturer

Air Liquide Medical Systems SA