Events

Recall of Spacer® INHALATION DEVICES INHALATION DEVICES

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 AstraZeneca.

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
    2009-04-06
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-tous-les-lots-du-dispositif-pour-inhalation-chambre-nes-spacer-r-references-acl-726-521-0-acl-726-522-7-acl-726-523-3
  • 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
    AstraZeneca, in agreement with Afssaps, is recalling all batches of the Spacer® INHALATION DEVICES INHALATION DEVICES (References: ACL 726 521.0, ACL 726 522.7, ACL 726 523.3) as a result of a risk of incorrect assembly of this device .. Indeed, it is important that the mouthpiece is connected to the chamber in the right direction because it has a unidirectional valve. However, AstraZeneca has received reports that it has been possible to insert the mouthpiece in the wrong direction, sometimes with significant clinical consequences. AstraZeneca will not be able to replenish pharmacies with new Nes Spacer® rooms. A letter is sent to doctors and pharmacists about alternative measures to take. Regarding the return of products in your possession, you are requested to complete the attached form and fax it back to the number specified on this form, so that our team can contact you as soon as possible. For any information, please contact 01 41 29 43 7. This information is intended for pharmacists, doctors, correspondents of materiovigilance for distribution where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. Read auss. Mail sent to pharmacists (06/04/2009) (23 KB Mail addressed to doctors (06/04/2009) (23 kB Return modality form (06/04/2009) (22 KB) Communiqué of 06 / 04/2009

Device

Spacer® INHALATION DEVICES INHALATION DEVICES
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    AstraZeneca

Manufacturer

AstraZeneca