Events

Recall of CustomEyes kit

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 BD France SAS.

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
    2008-01-31
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-kits-customeyes
  • 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    On 30/01/08, at the request of Afssaps, the company BD France SAS has withdrawn lots 7247645/7304708/7254211/7288250/7310917/7262567/7304613/7318565/7204006/7289434/7254224/7304813 / The medical device known as the CustomEyes kit, manufactured by BD Medical Ophthalmic Systems, as part of the of mismatch observed with the BD Plastipak Luer slip syringes included in these kits .. The company BD France SAS has directly notified the recipients of the incriminated lots with the enclosed message (30/01/2008) (21 KB) validated by the 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

CustomEyes kit
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BD France SAS

Manufacturer

BD France SAS
  • Source
    LAANSM