Events

Recall of DI-60HL

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.

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
    2006-12-19
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-tubulures-de-rechauffement-level-1-di-60hl-de-la-societe-smiths-medical
  • 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
    Afssaps was informed on December 8th, 2006 of a recall of normal heat-up tubes level 1 DI-60HL carried out by the company Smiths Medical on November 20th, 2006 following cases of rise in temperature beyond the programmed temperature warming liquid. The health facilities concerned by the recall received the attached letter (08/12/2006) (134 KB).

Device

DI-60HL
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical