Events

Recall of HEPAFIX biopsy set batch withdrawal

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 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
    2006-05-26
  • 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-lot-de-set-de-biopsie-hepafix-de-la-societe-b-braun-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
    The company B.Braun Medical withdrew from the market on May 24, 2006 the references 0008448H and 0008449J lot 5L 090 18701 of the medical device called "set biopsy HEPAFIX" following a mixture of references at the needle (the diameter of the needle may differ from that on the outer packaging labeling). The company has directly notified the recipients of the offending lot with the message attached (24/05/2006) (53 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

HEPAFIX biopsy set batch withdrawal
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B.Braun Medical

Manufacturer

B.Braun Medical