Events

Recall of 100cc silicone suction tanks with anti-reflux valv

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 Saint-Gobain Performance Plastics Francel.

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
    2010-05-05
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-reservoirs-de-succion-en-silicone-de-100cc-avec-valve-anti-reflux-saint-gobain-performance-plastics-france
  • 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 May 3, 2010, Saint-Gobain Performance Plastics Francel withdrew the lots from the market. 400409100. 40080910. 40060915. 400809202. 400109904. 400100931. 400809007 of the reference 3101-ASS 3101of the medical device called "100cc silicone suction tanks with anti-reflux valve", manufactured by SGPPL France, following a lack of sterility. The company Saint-Gobain Performance Plastics Francel directly notified the recipients of the incriminated lots with the enclosed message validated by Afssaps. (05/05/2010) (878 kb.) This information is intended for the directors and correspondents of materiovigilance for dissemination, where appropriate, to the departments concerned, the relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

100cc silicone suction tanks with anti-reflux valv

Manufacturer

Saint-Gobain Performance Plastics Francel