Events

Recall of LogiCal, TranStar, NovaTrans with Trigger flush

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 Smiths Medical International Ltd.

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
    2008-06-04
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-sets-de-pression-a-usage-unique-logical-transtar-novatrans-avec-tigger-flush-smithsmedical-international
  • 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 May 30, 2008, Smiths Medical France withdrew from the market batches manufactured between October 2007 and February 2008 medical devices called "LogiCal, TranStar, NovaTrans with Trigger flush", manufactured by Smiths Medical International Ltd, following the malfunction of a number of sets, for which the infusion rate is higher than the specified nominal value of 3 ml / h. This excess flow entails a risk of over-perfusion for the patient but also an error in reading the pressure. The company Smiths Medical France directly notified the recipients of the incriminated lots with the message attached (30/05/2008) (40 KB) validated 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

LogiCal, TranStar, NovaTrans with Trigger flush

Manufacturer

Smiths Medical International Ltd