Events

Recall of unkown device

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 N/A.

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
    2004-03-31
  • 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-plusieurs-lots-de-dispositifs-medicaux-de-differents-fabricants
  • 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
    Afssaps has asked 25 manufacturers to withdraw from the market, batches of medical devices sterilized with ethylene oxide by ESTER, for which sterility can not be guaranteed. This animal health measure (09/03/2004) (87 KB) follows an inspection conducted in early 2004 by Afssaps with ESTER, a sterilization subcontractor. The various manufacturers (see list below) attached: format pdf (31/03/2004) (118 ko) - excel format (31/03/2004) (111 ko)) directly informed their customers (end-users) .. Information / Recommendation (31/03 / 2004) (98 ko) of materiovigilance was sent to all the directors of health establishments, local correspondents of materiovigilance and hospital pharmacists.

Device

unkown device
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM