Events

Recall of 40ml sterile bottle under double packaging

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 FLD.

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
    2004-12-30
  • 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-du-dmdiv-flacon-40ml-sterile-double-emballage-de-par-f-l-d
  • 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 December 29, 2004, the company FLD withdrew from the market batch 031245 (per 20.07.12) of the in vitro diagnostic medical device called 40ml sterile bottle under double packaging - commercial reference 34 077 042 (manufacturer's ref .: BTP30-01 The company has directly notified the recipients of the offending lot by means of the enclosed message (29/12/2004) (94 ko). This information is intended for laboratory managers, directors of health establishments and to the correspondents of réactovigilance for diffusion, if necessary, to the services concerned.

Device

40ml sterile bottle under double packaging
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    FLD

Manufacturer

FLD
  • Source
    LAANSM