Events

Recall of Urinary calculus extractors DIMENSION and PLATINUM

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 BARD France.

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
    2004-01-15
  • 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-d-extracteurs-de-calculs-urinaires-de-la-societe-bard-france
  • 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
    In agreement with Afssaps, the company BARD France withdraws from the market all batches of references 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045370, 045390, 045490 medical devices called urinary calculus extractors DIMENSION and PLATINUM following the detection by the manufacturer, during routine quality controls, of the presence of micro - holes in the film of certain individual bags protecting sterility. No incident has been recorded so far. These devices are used in urology in particular, for removal under endoscopy of renal and ureteral stones. The recipients of the references and lots concerned are notified directly by the manufacturer.

Device

Urinary calculus extractors DIMENSION and PLATINUM
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BARD France

Manufacturer

BARD France