Events

Recall of Haemolite2 +

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 Haemonetics France.

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
    2005-09-28
  • 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-dispositif-de-lavage-pour-recuperateur-de-sang-autologue-haemonetics
  • 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
    Haemonetics France withdrew from the market on September 23, 2005 the QQ05045 batch of the medical device called "washing device for autologous blood collection Haemolite2 +, reference 193E following incidents due to a sticking fault of the pump line. directly warned the recipients of the offending batch with the message attached (23/09/2005) (64 KB) validated by the Afssaps. This information is intended for the directors of health establishments and correspondents materiovigilance premises for dissemination, where appropriate to the departments concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

Haemolite2 +

Manufacturer

Haemonetics France
  • Source
    LAANSM