Events

Recall of Dermabond and Dermabond Mini Dermabond

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 Ethicon.

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
    2011-02-11
  • 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-a-usage-cutane-dermabond-et-dermabond-mini-ethicon-rappel-de-lots
  • 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 the 10/02/2011, the company Ethicon removed from the market the attached lots of the medical device called "Dermabond and Dermabond Mini Cutaneous Glue", manufactured by Ethicon, LLC, Puerto Rico (USA) because some blisters of products have a problem of discoloration associated with the extension of the polymerization time of the glue. The company Ethicon has directly notified the recipients of the incriminated lots by means of the attached message validated by Afssaps (11/02 / 2011) (178 KB). This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities shall be informed of this measure by the manufacturer.

Device

Dermabond and Dermabond Mini Dermabond
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon