Events

Recall of MEDISET

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 Laboratories Paul Hartmannn.

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
    2010-03-16
  • 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-de-lots-d-un-dispositif-medical-mediset-trousse-de-soins-pour-ablation-de-fils-par-le-laboratoire-paul-hartmann
  • 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 15/03/2010, Laboratories Paul Hartmannn removed from the market batches 900701137 and 900801134 of the reference 470119/6 of the medical device called "MEDISET - Kit of care for ablation of threads" following the highlighting of a defect of the wire cutters present in these kits. The black plastic part around the axis of rotation is likely to break when using the scissors. The laboratories Paul Hartmann directly warned the recipients of the incriminated lots with the message attached (16/03/2010) (29 KB) validated by Afssaps. This information is addressed to directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

MEDISET

Manufacturer

Laboratories Paul Hartmannn
  • Source
    LAANSM