Events

Alerte De Sécurité sur Sterile Water for Irrigation 1000ml

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Baxter Healthcare Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-08-20
  • Date de publication de l'événement
    2012-08-20
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120820.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: baxter sterile water for irrigation 1000ml the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning sterile water for irrigation 1000ml manufactured by baxter healthcare ltd. the affected product code is ukf7114, lot no 12d10b26. this lot was supplied by baxter from 1 may 2012 to 22 may 2012 inclusive. there is a risk of contamination of this batch as there has been a report in france that bottles within this batch were contaminated with aspergillus. this case is still under investigation and the affected batch is being independently tested. meanwhile, customers are advised to quarantine bottles in the affected batch and liaise with baxter regarding availability of supplies and for updates. the mhra is liaising with baxter and will provide further updates as necessary. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts /index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 august 2012.

Device

Sterile Water for Irrigation 1000ml
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Sterile Water for Irrigation 1000ml
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd