Events

Recall of CELSITE BRACHIAL

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
    2004-03-05
  • 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-d-un-lot-du-dispositif-celsite-brachial-de-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
    In agreement with Afssaps, the company B.Braun Medical removed from the market the lot A0492270 of the reference 04433734 of the medical device called CELSITE BRACHIAL (implantable chamber) following a problem of compatibility between the peelable introducer 5F and the guide 0.035 due to a reduction in the diameter of the introducer, in response to a customer request .. The 5 recipients of this lot were warned directly by the manufacturer.

Device

CELSITE BRACHIAL
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B.Braun Medical

Manufacturer

B.Braun Medical