Events

Recall of Vacutainer Silica 10 ml;SST II Advance 8.5 ml

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 BECTON DICKINSON.

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
    2008-09-17
  • 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-tubes-de-prelevement-reference-367896-et-reference-366468-societe-becton-dickinson
  • 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, the company Becton Dickinson, informed on 15/09/08, the users of the Vacutainer Silica 10 ml sample collection tubes, reference 367896 and the SST II Advance 8.5 ml collection tubes, reference 366468 of the withdrawal several lots for lack of performance. The users of this device concerned by this defect, in France, have received the attached mail (17/09/2008) (22 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.

Device

Vacutainer Silica 10 ml;SST II Advance 8.5 ml
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON