Events

Recall of Cefpodoxime + clavulanic acid

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 OXOID.

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
    2005-03-16
  • 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-du-dmdiv-disques-cefpodoxime-acide-clavulanique-oxoid
  • 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
    Afssaps was informed by OXOID of the withdrawal of the market, on March 14, 2005, from lot 368726 of the in vitro diagnostic medical device known as the Cefpodoxime + clavulanic acid reference CT1596B disk set due to a lack of antibiotic concentration that could lead to a defect of detection of broad spectrum ßlactamases .. The company has directly notified the health facilities concerned with the attached message (14/03/2005) (76 ko) .. This information is intended for those responsible laboratories, the directors of health establishments and the reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Cefpodoxime + clavulanic acid
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    OXOID

Manufacturer

OXOID
  • Source
    LAANSM