Events

Recall of CYTOSOL saline solution

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
    2006-03-08
  • 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-solution-saline-cytosol-distribuee-par-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
    At the request of the manufacturer CYTOSOL Laboratories Inc., the company BECTON DICKINSON, distributor for France, withdraws from the market all batches of the medical device called "CYTOSOL saline solution 18 ml" and "BD Custom Eyes kit" references 581758 and 588100 following two cases of toxic syndrome reported in the USA related to the presence of endotoxins. The company has directly notified the recipients concerned with the message attached (08/03/2006) (20 KB) validated by Afssaps .. This information is addressed to the directors of health establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the ophthalmology and ophthalmic surgery departments. The relevant European Competent Authorities are informed of this measure. by the distributor.

Device

CYTOSOL saline solution
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON