Events

Recall of Custom CEC Synthesis Oxygenator Pack

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 LivaNova (Sorin).

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
  • Event ID
    201601546
  • Date
    2016-02-12
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/custom-pack-cec-custom-pack-cec-oxygenateur-synthesis-livanova-sorin-rappel-de-lots
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal carried out by LivaNova (SORIN BIOMEDICA CRM SRL). The users concerned have received the attached mail (12/02/2016) (1085 ko ). This security action is registered at ANSM under the number 201601546. You will be able to check its progress on the Directory of Materielovigilance Reports. by entering this registration number.

Device

Custom CEC Synthesis Oxygenator Pack
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    LivaNova (Sorin)

Manufacturer

LivaNova (Sorin)