Events

Rappel de Level One fluid heaters

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par SMITHS MEDICAL.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2007-08-28
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retraits-de-lots-de-tubulures-pour-rechauffeurs-de-fluides-level-one-series-h1000-smiths-medical
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    On 27/08/07, the company SMITHS MEDICAL removed from the market batches whose expiry is less than or equal to July 2011 references D50-DI50; D60-DI60; D70; D100-DI100 and D300-DI300 medical device called Level One fluid heaters (series H1000) due to a leakage problem. Recommendations. were issued by the manufacturer (May 2007) to users, pending the marketing of new, more secure tubings, including a test procedure to detect any leakage to be made prior to their use. The recall follows the reporting of new incidents despite these recommendations and the availability of the new tubing. The company SMITHS MEDICAL directly notified the recipients of the incriminated lots with the message attached (28/08/2007) (451 ko) validated by Afssaps. This information is addressed to the directors and correspondents of materotovigilance for diffusion if necessary to the services concerned. The competent European authorities have been informed by the competent German authority.

Device

Level One fluid heaters
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    SMITHS MEDICAL

Manufacturer

SMITHS MEDICAL
  • Source
    LAANSM