Events

Recall of COSEAL sealing gel

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 BAXTER.

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
    2010-01-21
  • 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-lots-de-gel-d-etancheite-coseal-de-la-societe-baxter
  • 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 January 20, BAXTER removed from the market batches HA080942, HA081101, HA081133, HA081217, HA090113, HA090226, HA090241 of references 934073 and 934074 of the medical device called "COSEAL sealing gel", as a result of stability results. out of specification which may lead to polymerization failure during application. The company BAXTER has directly notified the recipients of the incriminated lots with the message attached (21/01/2010) (33 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

COSEAL sealing gel
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER