Events

Recall of FLOVAL SE Flowmeters

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 Air Liquide Santé 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
    2008-03-04
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-debitmetres-a-bille-floval-se-societe-flow-meter-s-p-a
  • 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 29/02/08, Air Liquide Santé France withdrew from the market all the batches of the references cited in the attached message (29/02/2008) (23 KB) of the medical device called Ball Flowmeters " FLOVAL SE ", manufactured by Flow Meter, following a manufacturing defect highlighted on the notched fittings manufactured between 2005 and 2007 which may be at the tolerance limit set by the AFNOR NF S 90-116 standard. Air Liquide Santé France has directly notified the recipients of the offending batches by means of the enclosed message validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

FLOVAL SE Flowmeters

Manufacturer

Air Liquide Santé France