Events

Recall of Arterial and venous line batches for hemodialysis generator

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
    2006-10-10
  • 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-lignes-arterielles-et-veineuses-pour-generateur-d-hemodialyse-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    The company B.BRAUN has withdrawn from the market on October 4, 2006 lots 06D21934, 06E02934, 06E06934, 06E08934, 06E25934, 06F07934, 06F19934, 06G20934 of the medical device called arterial and venous lines reference 7210684 for hemodialysis generators B.Braun DIALOG more a few cases of visible pinching of the tube resulting in cracks resulting in leakage of rinsing liquid or blood. The company has directly notified the recipients of the incriminated lots with the attached message (10/10/2006) (13 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The relevant European competent authorities are informed of this defect by the manufacturer.

Device

Arterial and venous line batches for hemodialysis generator
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B.Braun

Manufacturer

B.Braun