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
    2011-01-31
  • 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-complement-au-rappel-du-21-01-2011
  • 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 28/01/2011, the UNOMEDICAL company informed Afssaps that the list of the lots diffused during the recall of the 20/01/201. , "Oxygen Masks and Unomedical Oxygen Tents" was incomplete. The same recall letter was sent back to the distributors and customers, along with the list of additional lots affected by this recall (in attachments (31/01/2011) (65 KB)).

Device

Oxygen Masks and Oxygen Tents
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    UNOMEDICAL

Manufacturer

UNOMEDICAL