Events

Recall of BD Plastipak syringes 10ml Luer

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
    2010-02-05
  • 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-du-lot-0912105-du-dipositif-medical-seringues-bd-plastipak-10ml-luer-becton-dickinson-france-s-a-s
  • 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
    On 03/02/2010, the company Becton Dickinson France SAS has withdrawn the lot 0912105 of the reference 302188 of the medical device called BD Plastipak syringes 10ml Luer, manufactured by Becton Dickinson (Spain). Following routine tests on the medical device: BD Plastipak ™ 10ml Luer Syringes, Becton Dickinson discovered a quality defect that could compromise the sterility of the medical device. Indeed, a percentage of syringes from the lot concerned had a tiny hole on the sterile unit package. Becton Dickinson France SAS directly notified the recipients of the offending lot with the enclosed message (05/02 / 2010) (31 kb) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

BD Plastipak syringes 10ml Luer
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON