Events

Recall of Pressure monitoring kit BD DTX Plus

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
    2002-07-24
  • 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-du-kit-de-surveillance-de-pression-de-la-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
    The company BECTON DICKINSON withdraws from the market lot 109101 of the reference 686363 and batches 107521 and 109198 of the reference 687162 of the medical device "pressure monitoring kit BD DTX Plus" following a possible failure of the fixation between the tubing and the Luer - Lock connections can cause the detachment of the tubing with a significant risk in terms of clinical consequences. BD DTX Plus pressure monitoring kits are single-use pressure lines for hemodynamic monitoring and pressure measurement.

Device

Pressure monitoring kit BD DTX Plus
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON