Events

Recall of PRORHINEL Spray, nasal solution under pressure

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 NOVARTIS.

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
    2005-03-25
  • 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-prorhinel-spray-solution-nasale-de-novartis-sante-familiale2
  • 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 NOVARTIS Santé Familiale laboratory withdraws from the market the lots 2002 074 to 2002 089 included and 2003 091 to 2003 115 inclusive of the medical device called PRORHINEL Spray, nasal solution under pressure, following the report of a case of detachment of the end of the diffuser and its housing in the nostril of the patient. This recall only concerns France. The recipients concerned by this recall are the pharmacists who are notified through wholesaler-dispatchers. For information, pharmacists in health facilities are informed by the system of fax alerts.

Device

PRORHINEL Spray, nasal solution under pressure
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    NOVARTIS

Manufacturer

NOVARTIS
  • Source
    LAANSM