Events

Recall of PRISMA sets for dialysis

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 GAMBRO.

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
    2005-11-23
  • 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-sets-prisma-pour-dialyse-de-la-societe-gambro2
  • 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    The company HOSPAL has withdrawn from the market on November 9th, 2005 the batches specified in the message of recall (23/11/2005) (40 ko) in annex, of the medical device called "sets PRISMA" manufactured by GAMBRO, following several cases of leaks on the intake pressure port, after disconnection of the patient. These sets are used in continuous extra-renal therapies. The company has directly notified the recipients of the incriminated lots with the message attached (23/11/2005) (74 ko) validated by the Afssaps. This information is addressed to the directors of health facilities and to the local correspondents for material vigilance for dissemination, where appropriate to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

PRISMA sets for dialysis
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    GAMBRO

Manufacturer

GAMBRO
  • Source
    LAANSM