Events

Recall of DUOFLO

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
    2002-03-20
  • 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-d-un-lot-de-dm-duoflo-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
    The BAXTER company withdraws from the market lot 05290106 the topical / surgical manual vaporizer medical device reference B2232000999999 following a signal of detachment of the spray nozzle of this device during its use and the potential risk for the patient in case this separation occur during a surgical procedure, since the spray tip is not radiopaque. This device is used for the application of fibrin glue .. Description of the incident: risk of detachment of the spray tip of this device during its use .. Consequences or risk: risk of loss of the tip at the level of the wound because it is not radiopaque .. Given the reduced number of recipients of this lot, they were warned directly by the laboratory .. Therefore, no alert number n 'has attributed to this withdrawal.

Device

DUOFLO
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER