Events

Alerte De Sécurité sur Guardian II Hemostasis Valve

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

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
    2016-03-30
  • Date de publication de l'événement
    2016-03-30
  • 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_20160330b.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: vascular solutions guardian ii hemostasis valve the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning guardian ii hemostasis valve manufactured by vascular solutions. the affected model numbers are fh101, fh101-t, fh101-25 and fh101-50. the affected lot numbers are 41817, 42029, 42068, 42409, 42410, 42687, 42688, 42689, 42691, 42692, 42693, 42699, 42700, 42701, 42986, 42987, 42988, 42989, 43186, 43187, 43188 and 43408. investigation of a recent complaint has made the manufacturer aware of a potential problem with the click version of the guardian ii hemostasis valve. the low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism. according to the manufacturer, no air ingress or patient harm has been reported. the manufacturer advises affected users to identify and remove all affected devices. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-21-march-to-25-march-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 march 2016.

Device

Guardian II Hemostasis Valve
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Vascular Solutions Guardian II Hemostasis Valve
  • Manufacturer
    Vascular Solutions

Manufacturer

Vascular Solutions