Events

Recall of Grasset AC6507 probes lot 03101443 PORGES company

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 PORGES.

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
    2004-04-19
  • 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-sondes-de-grasset-ac6507-lot-03101443-societe-porges
  • 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
    Afssaps was informed of a recall of bladder catheters Grasset AC6507 lot 03101443 made by the company PORGES March 19, 2004 following a non-compliance of the tensile strength. Health facilities concerned by the recall in France received the attached letter (19/04/2004) (116 KB). The other competent European authorities are not concerned by this recall.

Device

Grasset AC6507 probes lot 03101443 PORGES company
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PORGES

Manufacturer

PORGES
  • Source
    LAANSM