Events

Recall of UV-Flash system transfer line

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
    2004-11-09
  • 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-de-ligne-de-transfert-systeme-uv-flash-dialyse-peritoneale-societe-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 November 8, 2004, the BAXTER company withdrew the H03L12057 batch of the reference R5C4325 medical device called UV-Flash system transfer line used for peritoneal dialysis following the occurrence in France of twelve cases of disconnection between the tubing and the clamp. No serious medical consequences have been reported following these events thanks to the rapid implementation of prophylactic antibiotherapy. BAXTER has directly informed the recipients of the offending lot with the attached message (08 / 11/2004) (14 kb) validated by Afssaps. This information is addressed to the directors, pharmacists and local correspondents of materiovigilance for diffusion if necessary, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. Message Baxter (08/11/2004) (14 KB)

Device

UV-Flash system transfer line
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER