Events

Recall of EP 20 BB

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 PENTAIR.

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
    2007-03-14
  • 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-cartouches-filtrantes-pour-dialyse-par-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    The company GAMBRO has withdrawn from the market on March 9, 2007 the lots specified in the attached message, the medical device called "filter cartridges EP 20 BB for dialysis" manufactured by the company PENTAIR following the observation on 4 cartridges of a decline fast dechlorination efficiency a few minutes to a few hours after commissioning. The company has directly notified the recipients of the incriminated lots with the message attached (09/03/2007) (22 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary, to the services concerned. This reminder only concerns France.

Device

EP 20 BB
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PENTAIR

Manufacturer

PENTAIR
  • Source
    LAANSM