Events

Alerte De Sécurité sur Arrow Edge Hemodialysis Catherization Set Long-Term Access, Arrow NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access

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

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
    2014-02-11
  • Date de publication de l'événement
    2014-02-11
  • 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_20140211c.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: arrow international arrow edge hemodialysis catherization set long-term access, arrow nextstep antegrade hemodialysis catheterization set, long-term access the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning arrow edge hemodialysis catherization set long-term access, and arrow nextstep antegrade hemodialysis catheterization set, long-term access hemodialysis catheters, manufactured by arrow international, inc. the manufacturer has issued a voluntary recall for some lots of the hemodialysis catheter product codes due to receipt of complaints that the tunneling sheath packaged within the kits can crack during placement. if the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. the manufacturer advises users to cease use and distribution of stock of affected product and quarantine immediately. according to the local supplier, cemma enterprise, the devices were not distributed in hong kong. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con371783 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 february 2014.

Device

Arrow Edge Hemodialysis Catherization Set Long-Term Access, Arrow NextStep Antegrade Hemodialysis...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Arrow International Arrow Edge Hemodialysis Catherization Set Long-Term Access, Arrow NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access
  • Manufacturer
    Arrow International

Manufacturer

Arrow International