Events

Recall of DIDACTIC 60 ml L / L

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 DIDACTIC.

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
    2008-01-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-seringues-60-ml-de-la-societe-didactic
  • 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 December 28, 2007, the company DIDACTIC removed from market the 2007J01, 2007J15 and 2007E30 batches of the reference TL 99N of the medical device called syringes DIDACTIC 60 ml L / L, following reports reporting outbreaks of nuisance alarms on certain shoot -Seringues, inaccuracies in volumes taken and leaks .. The company DIDACTIC directly notified the recipients of the incriminated lots with the enclosed message validated by Afssaps (02/01/2008) (116 KB). This information is addressed to the directors of establishments, pharmacists and local correspondents of materiovigilance for dissemination if necessary to the services concerned. This recall concerns only France.

Device

DIDACTIC 60 ml L / L
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    DIDACTIC

Manufacturer

DIDACTIC
  • Manufacturer Parent Company (2017)
    Didactic
  • Source
    LAANSM