Events

Recall of OXEANE VERTE K5 and K15

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 AGA Medical.

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
    2003-09-02
  • 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-lots-de-bouteilles-d-oxygene-oxeane-verte-de-la-societe-aga-medical2
  • 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 AGA MEDICAL withdraws from the market a number of oxygen cylinders type OXEANE VERTE K5 and K15 equipped with a tap with debilitator wheel with integrated expansion type COMBISTAR following cases of rupture of the steering wheel. These bottles are identifiable by the presence of a white octagonal label located in the center of the manometer .. The recipients who are only structures providing medical oxygen home are warned directly by the company AGA. The references, batch numbers and bottle numbers concerned are also indicated directly to each recipient. The bottles concerned by this withdrawal have not been distributed to hospitals.

Device

OXEANE VERTE K5 and K15
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    AGA Medical

Manufacturer

AGA Medical
  • Source
    LAANSM