Events

Recall of Easypump Portable Diffuser

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 I-Flow Corporation.

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
    2006-01-30
  • 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-diffuseur-portable-easypump-distribue-par-b-braun-medical
  • 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
    B.Braun Medical withdraws from the market, at the request of the manufacturer I-Flow Corporation, the references and batches specified below, of the medical device known as "Easypump" following a report of a batch and reference error on the primary packaging. The references and lots concerned are:. Easypump ST 100-1 (box of 10) reference 4434350 lot 56279. Easypump LT 60-24 (box of 1) reference 4434367 lot 56285. The company has directly notified the recipients concerned with the enclosed message (30 / 01/2006) (25 kb) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned .. This reminder concerns only the La France.

Device

Easypump Portable Diffuser

Manufacturer

I-Flow Corporation
  • Source
    LAANSM