Events

Recall of Venous femoral cannula

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 SORIN GROUP.

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
    2006-12-11
  • 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-canules-femorales-veineuses-du-dm-de-la-societe-sorin-group
  • 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    The company SORIN GROUP has withdrawn from the market on December 8, 2006 lots 0600312000, 0600393000, 0600760000, 0600983000 of the reference V172-28 of the medical device called "venous femoral cannulas with armature" following a risk of blocking the shutter at the the central tubing of the cannula. The company has directly notified the recipients of the incriminated lots by means of the attached message (08/12/2006) (33 KB) validated by Afssaps. This information is addressed to the directors of health facilities and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Venous femoral cannula
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SORIN GROUP

Manufacturer

SORIN GROUP
  • Source
    LAANSM