Events

Recall of BD Vacutainer 0.105M sodium citrate tubes

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
    2002-06-21
  • 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-d-un-lot-de-tubes-bd-vacutainer-citrate-de-sodium-0-105m-de-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
    Becton Dickinson has withdrawn lot 2067271 (per 20.08.03) from the in vitro diagnostic medical device called BD Vacutainer 0.105M sodium citrate tubes, reference 367714, following a manufacturing defect corresponding to the possibility of absence of anticoagulant (sodium citrate) in some tubes. The tubes in this lot are distributed by Becton Dickinson, AES and SUBRA.

Device

BD Vacutainer 0.105M sodium citrate tubes
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON