Events

Recall of Surgical glue - GRF

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 Microval.

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
    2015-11-17
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/colle-chirurgicale-grf-microval-rappel
  • 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
    ANSM has been informed of the implementation of a product withdrawal carried out by MICROVAL. The two institutions concerned in France received the attached mail (17/11/2015) (25 KB). Read auss. Decision of 13 October 2015 suspending the manufacture, placing on the market, export, distribution and use of GRF sterile surgical glue, manufactured and placed on the market by MICROVAL, and the withdrawal of this Product (16/10/2015) (671 KB)

Device

Surgical glue - GRF
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Microval

Manufacturer

Microval
  • Manufacturer Parent Company (2017)
    Microval
  • Source
    LAANSM