Events

Alerte De Sécurité sur NextStep Antegrade Chronic Hemodialysis Catheter

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.

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
    2011-08-05
  • 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_20110805.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
    Fda class i recall: arrow nextstep antegrade chronic hemodialysis catheter manufactured between april 14, 2011 and may 9, 2011 it has come to our attention that the u.S. food and drug administration (fda) has issued a class i recall to healthcare professionals followed by complaints received by the manufacturer indicating breakage and/or separation of the stylet within the arrow nextstep antegrade catheters. the arrow nextstep antegrade catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. affected models include: model no. lot no. cs-15192-ixm rv1034909 cs-15232-ixm rv1034911 cs-15272-ixm rv1034912 cs-15312-ixm rv1034913 cs-15422-ix rv1034914 cs-15502-ix rv1034915 according to the supplier, the affected product was not distributed in hong kong. if you happen to have the affected product in hand, you are advised to contact your supplier for necessary actions. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm266463.Htm.

Device

NextStep Antegrade Chronic Hemodialysis Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [5 Aug 2011] Arrow NextStep Antegrade Chronic Hemodialysis Catheter manufactured between Apr 14, 2011 and May 9, 2011
  • Manufacturer
    Arrow

Manufacturer

Arrow