Events

Recall of Dolphin inflation systems

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 Sedat.

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
    2003-05-02
  • 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-dispositifs-d-inflation-dolphin-pour-ktr-a-ballonnet-par-la-societe-sedat
  • 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
    Sedat informed AFSSAPS of a reminder it issued on 11 April 2003 concerning Dolphin inflation systems for balloon catheters. Sedat sent the attached mail (05/05/2003) (136 KB) on April 11 to the 17 user centers and 2 vending companies, for the attention of pharmacy services.

Device

Dolphin inflation systems
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Sedat

Manufacturer

Sedat
  • Source
    LAANSM