Events

Recall of Blepharostat

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 3S Medikal Laboratory.

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
    2004-05-17
  • 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-de-blepharostats-du-laboratoire-3s-medikal
  • 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
    At the request of the Afssaps and following an inspection, the 3S Medikal Laboratory withdraws from the market the 030825 batch of the medical device called blepharostat following the absence of CE marking of conformity and validation of the sterilization. These devices are distributed by the PRODIS company which will directly inform the users of this lot.

Device

Blepharostat

Manufacturer

3S Medikal Laboratory
  • Source
    LAANSM