Events

Recall of RP / VARD / 20;RP / VARD / 35

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.

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
    2008-03-21
  • 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-raccords-avec-double-valve-medex
  • 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 March 19, 2008, the company MEDEX withdrew from the market the batches specified in appendix references RP / VARD / 20 and RP / VARD / 35 of the medical device called connection with double valve, following a claim reporting a blood reflux from the patient to the device placed upstream .. The company MEDEX has directly notified the recipients of the incriminated lots with the message attached (21/03/2008) (45 KB) validated by the Afssaps .. This information is intended to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities will be informed of this measure by the manufacturer.

Device

RP / VARD / 20;RP / VARD / 35
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    MEDEX

Manufacturer

MEDEX
  • Manufacturer Parent Company (2017)
    Guerbet
  • Source
    LAANSM