Events

Alerte De Sécurité sur hook-up kits containing non-sterile alcohol prep pads

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

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
    2011-11-23
  • 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_20111123.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
    Mhra field safety notice: spacelabs healthcare hook-up kits containing non-sterile alcohol prep pads the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on spacelabs healthcare’s hook-up kits containing non-sterile alcohol prep pads. spacelabs healthcare reported that non-sterile alcohol prep pads that contained in some of their hook-up kits, may have the presence of a bacterium, bacillus cereus, which could lead to life-threatening infection. spacelabs healthcare suggests the users to stop using these alcohol prep pads immediately and dispose them according to hospital or clinic protocol. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

hook-up kits containing non-sterile alcohol prep pads
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Spacelabs Healthcare hook-up kits containing non-sterile alcohol prep pads
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare