Events

Recall of VENATECH LP

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 B.Braun.

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
    2005-10-07
  • 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-filtres-venatech-lp-brachial-de-la-societe-b-braun
  • 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    The company B.Braun has withdrawn from the market on October 6, 2005 all the batches "old generation" of the medical device called VENATECH LP brachial filters reference 4435133 following difficulties encountered during the installation of one of these devices "old generation". In France, only batches FO201720, FO262480, FO348010, FO358350, FO474690 are affected by this recall measure. The company has directly notified the recipients of the offending lot with the message attached (06/10/2005) (326 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

VENATECH LP
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B.Braun

Manufacturer

B.Braun