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
    2006-04-12
  • 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-gambro
  • 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    The company GAMBRO has withdrawn from the market in November 2005, 15 batches of the medical device called "sets PRISMA" distributed by HOSPAL, following several cases of leaks on the intake pressure, after disconnection of the patient (message of 23/11 / 0.) .. As new claims have been reported on batches not listed during this first recall, GAMBRO extends its recall to all batches manufactured before the implementation of the corrective actions (12/04/2006) (25 ko ) (all lots prior to lot 05J2796P, not included). Pending the end of the recall and the implementation of additional preventive actions, instructions for use (12/04/2006) (43 KB) are recalled. The distributor HOSPAL has directly notified the recipients of the incriminated lots with the attached message (12/04/2006) (25 ko). This information is addressed to the directors of health establishments and local correspondents. materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

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

Manufacturer

GAMBRO
  • Source
    LAANSM