Events

Recall of Implantable Chamber Introduction System Bundle Removals

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 Tyco Healthcare.

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
    2005-07-12
  • 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-systeme-d-introduction-pour-chambre-implantable-tyco-healthcare
  • 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
    Tyco Healthcare has withdrawn from the market on July 11, 2005 the references and batches specified in the appendix (11/07/2005) (11 KB), of the medical device called "introduction system for chemoSite implantable chamber" following reports (reported to the introducer supplier) cracks of the base and the fins of the introducer sheath and peelability difficulties of the sheath in use. The company has directly notified the recipients of the incriminated lot with the message attached (11/07/2005) (13 KB) validated by the Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Implantable Chamber Introduction System Bundle Removals
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Tyco Healthcare

Manufacturer

Tyco Healthcare
  • Source
    LAANSM