Events

Recall of TRANSFUSEND

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 SENDAL France.

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
    2007-10-11
  • 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-transfuseurs-transfusend-sendal-france
  • 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
    On October 10, 2007, the company SENDAL France withdrew from the market lot H24746 of the medical device called TRANSFUSEND, manufactured by SENDAL SA, following the detection of a labeling error (11/10/2007) (14 ko ) concerning the CE marking of this device. This information is intended for pharmacists and local correspondents of materiovigilance for dissemination where appropriate to the services concerned.

Device

TRANSFUSEND
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SENDAL France

Manufacturer

SENDAL France
  • Source
    LAANSM