Events

Recall of AESCULAP ​​AG Co KG

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
    2007-11-16
  • 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-deux-references-de-caspas-applier-pour-yasargil-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
    On 15/11/07, the company B.Braun removed from the market the medical devices called CASPAR applier for Yasargil mini titanium aneurysm clips - reference FT420T and CASPAR app for Yasargil standard titanium aneurysm clips - referenceFT430T manufactured by AESCULAP ​​AG Co KG, continued to the notification of a case of rupture of the internal cane. The company B.Braun has directly notified the recipients of the offending products with the message attached (16/11/2007) (119 KB) validated by the Afssaps. This information is addressed to the directors and correspondents of material / réactovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

AESCULAP ​​AG Co KG
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B.Braun

Manufacturer

B.Braun