Events

Recall of SHILEY TRACHEOSOFT XLT

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
    2004-07-19
  • 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-xlt-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
    In agreement with Afssaps, TYCO Healthcare withdraws from the market all batches of the references specified in the appendix of the medical device known as SHILEY TRACHEOSOFT XLT long and flexible tracheostomy tubes due to a risk of separation between the cannula and the fitting, which may lead to a migration of the cannula in the airways .. No incident has been recorded so far, in France. The health facilities concerned by this recall are notified directly by the company TYCO Healthcare by means of the message attached (19/07/2004) (20 KB). The recall concerns only the XLT models and does not concern the tracheostomy tubes of the SHILEY type and of the TRACHEOSOFT type of the same company.

Device

SHILEY TRACHEOSOFT XLT

Manufacturer

TYCO Healthcare
  • Source
    LAANSM