Events

Recall of Infusor SV2 and syringe

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
    2009-03-10
  • 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-lot-infusor-sv2-et-seringue-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
    On March 6, 2009, the company BAXTER withdrew from the market the 2008K21 batch of the reference 2C1702KD of the medical device called "Infusor SV2 and syringe" following an error on the refund sticker. The sticker corresponds, in fact, to the product "Intermate SV100" instead of "Infusor SV2". The product concerned, apart from the error on the sticker, complies with the product specifications. The BAXTER company has directly notified the distributors of the offending lot who will inform the recipients concerned with the enclosed message (10/03/2009) (30 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. Given the small number of recipients, no alert number has been assigned to this withdrawal.

Device

Infusor SV2 and syringe
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER