Events

Recall of Electrodes PROBE Plus I- Electrochirugical System Ethicon Endo-Surgery

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
    2008-12-12
  • 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-du-dispositif-medical-electrodes-probe-plus-i-systeme-electrochirugical-ethicon-endo-surgery-ethicon-sas
  • 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    On 09/12/2008, the company ETHICON SAS has withdrawn from the market the batches having an expiry date between September 2012 and September 2013 references EPS01, EPS03, EPS06, EPS07, EPS09 of the medical device called: Electrodes PROBE Plus I- System Electrochirugical Ethicon Endo-Surgery, manufactured by Ethicon Endo-Surgery, Inc. in the United States. As a result of several claims, Ethicon Endo-Surgery has identified corrosion spots on the steel end. Thus, small amounts of nickel can be released and lead to manifestations of nickel allergy. The company ETHICON SAS has directly notified the recipients of the incriminated lots with the message attached (12/12/2008) (714 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Electrodes PROBE Plus I- Electrochirugical System Ethicon Endo-Surgery
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon