Events

Recall of Infusion and blood collection

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 DIDACTIC.

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
    2008-07-25
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-dispositifs-medicaux-pour-perfusion-et-pour-prise-de-sang-de-la-societe-didactic
  • 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 22/07/2008, the company Didactic removed from the market the lots of references listed in the appendix of the recall letter of the medical devices for infusion and blood collection, manufactured by DIDACTIC, sterilized and conditioned by STERLINE, following the highlighted during an inspection of the non-compliance of the method of sterilization with ethylene oxide (EO). Indeed, certain cycles of sterilization were carried out with quantities of sterilizing gas (OE) lower than the quantity defined during the internal validation. The company DIDACTIC has directly notified the recipients of the incriminated lots with the attached message (25/07/2008) (68 KB) validated by Afssaps. This information is intended for directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The competent European authorities (concerned) are informed of this measure by the manufacturer.

Device

Infusion and blood collection
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    DIDACTIC

Manufacturer

DIDACTIC
  • Manufacturer Parent Company (2017)
    Didactic
  • Source
    LAANSM