Events

Alerte De Sécurité sur Portex Low Dead Space Connector with Sideport

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

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
    2014-06-13
  • Date de publication de l'événement
    2014-06-13
  • 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_20140613.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: smiths medical portex low dead space connector with sideport the united states food and drug administration (fda) has issued a medical device safety alert concerning portex low dead space connector with sideport [product reorder no.: 10035-05ps; lot no.: 2553426], manufactured by smiths medical asd, inc. the affected products were distributed in november 2013. one lot of 3.0mm sized connectors, product reorder no. 10035-05ps, lot 2553426 were placed in packages labeled as 3.5mm. affected users are advised to examine their inventory and remove all affected products. for details, please refer to the following fda website:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm400982.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 june 2014.

Device

Portex Low Dead Space Connector with Sideport
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Smiths Medical Portex Low Dead Space Connector with Sideport
  • Manufacturer
    Smiths Medical ASD

Manufacturer

Smiths Medical ASD