Events

Recall of DYONICS 25

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 SMITH and NEPHEW.

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
    2009-06-04
  • 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-de-tubulures-pour-systeme-dyonics-25-smith-et-nephew
  • 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 02/06/09, the company SMITH and NEPHEW removed from the market the batches of the references cited in the attached recall message of the named medical devices (tubings). DYONICS 2. Fluid Management System Disposable Inflow / Outflow Tubeset With Single Suctio. Disposable inlet / outlet manifold for fluid management system (simple suction) DYONICS 2. Fluid Management System Disposable Inflow / Outflow Tubeset With Forked Suctio Disposable inlet / outlet tubing for fluid management system (suction in This recall follows a manufacturing defect of the plastic trays in which these pipes are conditioned.This manufacturing defect can potentially compromise the sterility of these pipes.The company SMITH and NEPHEW directly warned the recipients of the batches in question. the attached message (04/06/2009) (24 ko) validated by Afssaps This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

DYONICS 25
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SMITH and NEPHEW

Manufacturer

SMITH and NEPHEW
  • Source
    LAANSM