Events

Recall of Venous line BL 352

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 BELLCO SOLUDIA.

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
    2006-06-29
  • 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-ligne-veineuse-de-la-societe-bellco-soludia
  • 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    The company BELLCO SOLUDIA has withdrawn from the market on June 27, 2006 batches 06850047 and 06850053 of the medical device called "venous line BL 352" reference IB0432640 used in hemodialysis following a report of micro-leaks .. The company has directly notified the recipients of lots incriminated using the attached message (29/06/2006) (14 ko) validated by Afssaps .. This information is addressed to the directors of health facilities and local correspondents of materiovigilance for dissemination, where applicable to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

Venous line BL 352
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BELLCO SOLUDIA

Manufacturer

BELLCO SOLUDIA
  • Source
    LAANSM