Events

Recall of Hilite pediatric oxygenator batches

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 MEDOS.

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
    2003-05-13
  • 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-par-la-societe-medos-de-lots-d-oxygenateurs-pediatriques-hilite
  • 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
    In agreement with Afssaps, the company MEDOS has decided to recall all batches of all models of pediatric oxygenators Hilite manufactured between 2001 and June 2002. MEDOS sent on May 12, 2003 the enclosed mail (13/05/2003 ) (13 KB) at the 5 user centers, the local correspondents of materiovigilance for pharmacies and cardiac surgery departments. This recall has been made in all European countries where this product has been marketed.

Device

Hilite pediatric oxygenator batches
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    MEDOS

Manufacturer

MEDOS
  • Source
    LAANSM