Events

Recall of Light Wand Orotracheal Lignted, Teleflexmedical

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 Vital Sign Colorado Inc.

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
    2008-10-22
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/light-wand-orotracheal-lignted-teleflexmedical
  • 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
    On 17/10/2008, Teleflexmedical SAS withdrew from the market lot 6730C of the reference (VS) 3910 of the medical device called: Light Wand Orotracheal Lignted, Teleflexmedical, manufactured by Vital Sign Colorado Inc, following two complaints in the United States concerning the detachment of the light end protector (transparent plastic cap) at the distal end of the mandrel. This defect can lead to complications during intubation and may require fibroscopy. The company Teleflexmedical has directly notified the recipients of the offending lot with the enclosed message validated (22/10/2008) (22 KB) by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Light Wand Orotracheal Lignted, Teleflexmedical

Manufacturer

Vital Sign Colorado Inc
  • Source
    LAANSM