Events

Recall of Stellant double syringe kits

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 MEDRAD Europe.

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
    2004-11-10
  • 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-lots-de-seringues-doubles-stellant-de-la-societe-medrad
  • 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 was informed on 3 November 2004 by the company MEDRAD Europe of a withdrawal from the market on the same date, batches between 38321 and 45666 references SDS-CTP-QFT and SDS-CTP-SPK of the medical device called Stellant double syringe kits due to the risk of presence in a very small percentage, of a small notch in the protective strip of the tray. These syringes are used with CT injectors. The company MEDRAD Europe and MEDRAD France have directly informed the recipients of these lots (distributors and / or health facilities) with the help of the message attached (03/11/2004) (117 ko) .. The relevant European Competent Authorities have been informed of this measure by the manufacturer.

Device

Stellant double syringe kits
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    MEDRAD Europe

Manufacturer

MEDRAD Europe
  • Source
    LAANSM