Events

Recall of Secure System and Kids Kit Collection Sites

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 Medex 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
    2004-10-25
  • 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-site-de-prelevement-secure-system-et-kids-kit-de-medex-medical
  • 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 October 22, 2004, the company Medex Medical withdrew from the market the references and batches specified in the attached list (25/10/2004) (9 ko) in annex of the medical device called "Secure System" and "Kids Kit" site sampling due to a risk of development of fracture lines in the body of this site, which can weaken the whole and cause dislodgment of the septum .. No report has been reported in Europe to date. The Medex Medical company warned the users directly with the attached message (25/10/2004) (12 KB) validated by Afssaps. This information is addressed to the directors and local correspondents of materiovigilance for diffusion to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. list of references and lots (25/10/2004) (9 ko message Medex Medical (25/10/2004) (12 ko)

Device

Secure System and Kids Kit Collection Sites
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Medex Medical

Manufacturer

Medex Medical
  • Source
    LAANSM