Events

Recall of 2ml tank for external insulin pump

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 Animas / Novalab.

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
    2011-03-09
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/reservoir-2ml-pour-pompe-a-insuline-externe-animas-novalab-rappel-de-lot
  • 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
    In agreement with Afsaps, the company Novalab France, as a distributor for the company Animas, informed, on 04/03/2011, the users of Animas insulin pump reservoirs of 2.0ml of the recall of a lot. The users concerned, in France, have received one of the attached letters. providers (09/03/2011) (34 ko patients (09/03/2011) (23 ko hospitals (09/03/2011) (34 KB) The competent European authorities have been informed of this measure by the manufacturer. This information is intended for home health providers and directors of health establishments and local correspondents of materiovigilance for dissemination to the services concerned.

Device

2ml tank for external insulin pump
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Animas / Novalab

Manufacturer

Animas / Novalab
  • Source
    LAANSM