Events

Recall of Delivery Tubing for 6060 / Baxter Infusion Pump

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
    2004-12-06
  • 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-de-tubulures-d-administration-pour-pompe-de-perfusion-6060-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
    The company Baxter has withdrawn from the market on December 3, 2004, the references and batches specified in the appendix, the medical device called "infusion pump administration tubing 6060 with Autoclamp device" following the risk of free flow related to the absence of a cylindrical piece on the cassette, which prevents the pump from clogging the tubing and may result in drug overdose. No case has been reported in Europe .. The company has directly notified the recipients of references and offending batches using the message attached (03/12/2004) (29 KB) validated by Afssaps. This information is addressed to the directors of establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the departments concerned .. The relevant European Competent Authorities are informed of this measure by the manufacturer. References and offending lots (03/12/2004) (29 ko)

Device

Delivery Tubing for 6060 / Baxter Infusion Pump
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER