Recall of Tubulure peristaltique pump

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 SATELEC SAS.

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
    2007-09-27
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • 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 25 September 2007, SATELEC France withdrew from the market the batch 2003385 references (x10) F34702 of the medical device called Tubulure peristaltique pump, manufactured by SATELEC SAS, following the highlighting of non-compliant results during checks of sterility. The SATELEC SAS company has directly notified the recipients of the offending batch with the message attached (27/09/2007) (23 KB) validated by the Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant competent authorities are informed of this measure by the manufacturer.

Device

  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM