Events

Recall of unkown device

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 N/A.

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
    2003-10-13
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/suspension-d-utilisation-de-certains-dispositifs-medicaux-sterilises-a-l-oxyde-d-ethylene
  • 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
    The use of medical devices, sterilized with ethylene oxide by the company "HW ANDERSEN" located in LOOS (North), is suspended until this company whose main activity is the subcontracting of sterilization to ethylene oxide medical devices on behalf of health facilities is able to provide all guarantees of compliance of its activity with the requirements of the standard NF EN 550 that it claims and which is mandatory in the context hospital sterilization. Attached Decision (19/09/2003) (74 KB) This decision is effective as of September 24, 200. Customers of Andersen have been notified directly.

Device

unkown device
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM