Events

Alerte De Sécurité sur Hudson RCI Pediatric Anaesthesia Breathing Circuits

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

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
    2014-10-08
  • Date de publication de l'événement
    2014-10-08
  • 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_20141008.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: teleflex medical hudson rci pediatric anaesthesia breathing circuits the united states food and drug administration (fda) issued a medical device safety alert concerning hudson rci pediatric anaesthesia breathing circuits, manufactured by teleflex medical. the affected products were manufactured from march 2013 to july 2014 and distributed from june 2013 to may 2014. according to the fda, the ends of the devices may crack or break before or during use. this could cause serious health risks, including delayed patient treatment and breathing difficulties if not replaced immediately. use of this device may also cause death. on september 8, 2014, the manufacturer sent customers an urgent medical device recall letter explaining the device problem and actions to be taken. the manufacturer recommends the following actions:- stop using the devices. remove the devices from inventory and stop distribution. for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm417868.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm417731.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 october 2014.

Device

Hudson RCI Pediatric Anaesthesia Breathing Circuits
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Teleflex Medical Hudson RCI Pediatric Anaesthesia Breathing Circuits
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical