Events

Recall of HYGROFLUX TRACHEO

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 VYGON.

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
    2006-09-19
  • 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-lot-de-nez-artificiel-hygroflux-tracheo-de-la-societe-inmed-distribue-par-vygon
  • 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
    The company VYGON has withdrawn from the market on September 18, 2006 the lot 163132 of the medical device called HYGROFLUX TRACHEO reference 501.20 manufactured by INMED following several incidents of lack of oxygen supply. This device is an artificial nose for moistening and warming inspired gases that includes a connector for oxygen. The company has directly notified the recipients (some health facilities, associations and home care resellers) using the enclosed mail (18/09/2006) (31 KB). This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. This reminder only concerns France.

Device

HYGROFLUX TRACHEO
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    VYGON

Manufacturer

VYGON