Events

Recall of Valve Ruben with keying

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 Intersurgical.

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
    2009-12-24
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-du-dispositif-medical-valve-de-ruben-avec-detrompeur-par-la-societe-intersurgical
  • 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 23/12/09, the company Intersurgical removed from the market lots 30907162 and 30908794 of the reference 7562710 of the medical device called Valve Ruben with keying, manufactured by Intersurgical, following the discovery of leaks on the respiratory cone that may appear after the reassembly of the valves after their decontamination. The company Intersurgical has directly notified the recipients of the incriminated lots with the message attached (24/12/2009) (29 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities shall be informed of this measure by the manufacturer.

Device

Valve Ruben with keying
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical