Events

Recall of ALTHANE A-18 dialysis machines

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
    2001-09-01
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/suspension-d-utilisation-et-rappel-de-tous-les-dialyseurs-althane-a-18
  • 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 September 1, 2001, Baxter sent a warning message to the physician in charge and / or pharmacist in charge of 9 hemodialysis centers in possession of ALTHANE A-18 dialysis machines, to inform them of the suspension of use and all batches of dialyzers ALTHANE A-18 are recalled. See also the press release of 01/09/0. . Alert message to the physician in charge and / or pharmacist in charge of the center (Copy to the materiovigilance correspondent). September 1, 2001. Subject: ALTHANE A-18 dialysis machine (code 237018. Dear Doctor, Our company has recalled in Spain on August 31, 2001 two batches of ALTHANE A-18 dialyzers, following the deaths of 10 people. recalled, are not marketed in France .. Although there is no evidence of a link between our dialyzers and the death of these patients, this action was initiated as a precautionary measure in the interest of the safety of patients. We have been informed that other possible causes unrelated to dialyzers are being evaluated in the Spanish centers that reported these events. "The analyzes conducted to date on A-18 dialysers revealed no anomaly .. Our traceability allowed us to identify that your center uses this type of ALTHANE A-18 dialyser. At the request of the Afssaps, we proceed to the recall of all ALTHANE A-18 dialyzer batches. in your possession will have to We will be returned as soon as possible. Our services will contact you to organize with you the conditions of recovery of these products. In addition, we ask that you immediately stop using these devices and inform the centers or patients to whom this device has been provided. For any additional information, a telephone number is at your disposal: 01 34 61 53 3. Please accept, Dear Doctor, the assurance of our highest consideration .. Nicole Denjo. Director, Global Vigilance. Baxter, Renal Therapy Division

Device

ALTHANE A-18 dialysis machines
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Baxter

Manufacturer

Baxter
  • Source
    LAANSM