Events

Recall of Covered duodenal prostheses

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 MI Tech.

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
    2007-04-12
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-protheses-duodenales-couvertes-de-la-societe-mi-tech
  • 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
    The MI Tech company has withdrawn from the market on April 10, 2007 all batches manufactured before February 2007 of the medical device called "covered duodenal prostheses" references NDC 18 090 180 and NDC 18 110 180 following a defect in the silicone that may cause problems potential when laying. The distributor LIFE Partners Europe directly notified the recipients of the incriminated batches by means of the message attached (10/04/2007) (17 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary, to the services concerned.

Device

Covered duodenal prostheses
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    MI Tech

Manufacturer

MI Tech
  • Source
    LAANSM