Events

Recall of NEWFILL®, lyophilisate for injectable suspension

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 DERMIK LABORATORIES.

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
    2010-05-21
  • 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-d-un-lot-du-dispositif-medical-newfill-r-lyophilisat-pour-suspension-injectable-par-sanofi-aventis-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 21/05/2010, Aventis Pharma SA withdrew from the market lot A9032 of the medical device called NEWFILL®, lyophilisate for injectable suspension, manufactured by DERMIK LABORATORIES, following the detection of an abnormally high number of claims in the United States, for clogged needles preventing injection of the suspension into the patient. The company Aventis Pharma SA has directly notified the recipients of the offending lot with the message attached (21/05/2010) (15 KB) validated by Afssaps. This information is addressed to the directors, correspondents of materiovigilance and pharmacists for distribution if necessary to the services and prescribers concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

NEWFILL®, lyophilisate for injectable suspension

Manufacturer

DERMIK LABORATORIES
  • Source
    LAANSM