Events

Recall of Renu Multiplus, multifunctional solution and Renu MPS, multifunctional 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 Chauvin and Bausch and Lomb France.

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
    2010-07-07
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/renu-multiplus-solution-multifonctions-et-renu-mps-solution-multifonctions-chauvin-et-bausch-and-lomb-france-retrait-de-lots
  • 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    On 06/07/2010, the company CHAUVIN and the company BAUSCH and LOMB France have withdrawn from the market, as a precautionary measure, the batches of the references listed in the appendix (07/07/2010) (15 ko), medical devices called RENU MULTIPLUS, multifunctional solution and RENU MPS, multifunctional solution manufactured by Bausch & Lomb IOM (Italy), following the highlighting of out-of-trend results observed during the stability studies. The specifications are, to date, in compliance and do not call into question the safety and efficacy of the product. No adverse effects have been reported to the laboratory. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned as well as pharmacists and opticians. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Renu Multiplus, multifunctional solution and Renu MPS, multifunctional solution

Manufacturer

Chauvin and Bausch and Lomb France