Events

Recall of TRACHEOSOFT PERC Percutaneous

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
    2006-04-07
  • 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-canules-de-tracheotomie-de-la-societe-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
    The company TYCO HEALTHCARE withdrew from the market on April 5, 2006, the lots whose expiry date is between 2008 and 2010 inclusive (N of lot starting with 2003, 2004 or 2005) of the medical device called "tracheostomy tubes" 8.0 mm TRACHEOSOFT PERC Percutaneous "reference 137-80, following incidents reporting detachment of the locking system of the collar that can allow the cannula to migrate into the trachea .. The company has directly notified the recipients of the incriminated lots using of the message attached (05/04/2006) (188 ko) 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 .. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

TRACHEOSOFT PERC Percutaneous
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Tyco Healthcare

Manufacturer

Tyco Healthcare
  • Source
    LAANSM