Events

Recall of INFUSOR and KIT INFUSOR 1 DAY

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
    2007-12-14
  • 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-d-infusor-et-kit-infusor-1-jour-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
    INFUSOR 1 DAY: Portable diffuser 2 ml / hour with flexible flow regulator tubing - product reference: 2C1071KJP - batch numbers: 07E037, 07E038, 07E039, 07E055, 07E056, 07F030, 07G003, 07G043, 07H004 and 07H005. and KIT INFUSOR 1 DAY: portable diffuser 2 ml / hour with flexible flow regulating tubing and syringe - product reference: 2C1071KJD - lot numbers: 2007F29, 2007I12, 2007J19 and 2007K02. manufactured by BAXTER (Belgium) following reports of leaks. The BAXTER company has notified the recipients of the incriminated lots with the message attached (14/12/2007) (39 KB) validated by Afssaps. This information is addressed to the directors, correspondents of materiovigilance, pharmacists and hospital pharmacists for diffusion where appropriate to the services concerned. The competent European authorities are informed of this measure by BAXTER.

Device

INFUSOR and KIT INFUSOR 1 DAY
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER