Events

Recall of POLYSITE 1000 series

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 PEROUSE.

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
    2006-07-06
  • 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-chambre-a-catheter-implantable-polysite-veineux-de-la-societe-perouse
  • 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 PEROUSE withdrew from the market on June 30, 2006 the references and the batches specified (30/06/2006) (15 KB) in the appended reminder message, of the medical device called "modular venous catheterization chamber POLYSITE 1000 series - Adult Standard and Adult Large Flow "following reports opening the boxes after implantation .. The company has directly notified the recipients of the references and the incriminated lots with the message attached (30/06/2006) ( 18 kb) validated by Afssaps. Important information relating to the management of patients already implanted is addressed to the concerned physicians. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned. competent European authorities concerned are informed of this measure by the manufacturer.

Device

POLYSITE 1000 series
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PEROUSE

Manufacturer

PEROUSE
  • Source
    LAANSM