Events

Recall of Oxygen masks and oxygen tents

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 Unomedical.

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
    2011-01-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/masques-a-oxygene-et-tentes-a-oxygene-unomedical-retrait-de-lots
  • 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
    On 19/01/2011, the company UNOMEDICAL removed from the market the attached lots (21/01/2011) (12 ko) oxygen masks and oxygen tents Unomedical, manufactured by UNOMEDICAL SA, following the presence of a potential irregularity of the aforementioned goods. On some Oxygen Masks and Oxygen Tents, a sticky substance inside and / or outside the mask may appear within 6-8 months of product manufacture. The UNOMEDICAL company has directly notified the recipients of the incriminated lots with the message attached (21/01/2011) (54 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. Read auss. Oxygen masks and oxygen tents - Unomedical - Supplement to the Recall of 21/01/2011

Device

Oxygen masks and oxygen tents
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Unomedical

Manufacturer

Unomedical