Events

Alerte De Sécurité sur ABG-HM-1 Hummi Micro-Draw Blood Transfer Device

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

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
    2016-05-27
  • Date de publication de l'événement
    2016-05-27
  • 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_20160527.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: hummingbird med devices inc abg-hm-1 hummi micro-draw blood transfer device the united states food and drug administration (fda) has issued a medical device safety alert concerning abg-hm-1 hummi micro-draw blood transfer device, manufactured by hummingbird med devices inc. the affected devices are identified as follows:- lot numbers: 15180, 15286, 15287, 15300, 15305 manufacturing dates: june 29, 2015 to december 2, 2015 distribution dates: october 26, 2015 to november 18, 2015 according to the fda, the manufacturer is recalling the hummi micro-draw blood transfer device because the y-shaped connector and the yellow tube may disconnect from each other prior to or during use. this could lead to blood or fluid leakage. blood or fluid loss may result in serious adverse health consequences, including death. the manufacturer sent notification letters to affected customers informing them that the identified lots should not be used and product replacement would be arranged. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm503695.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm503689.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 may 2016.

Device

ABG-HM-1 Hummi Micro-Draw Blood Transfer Device

Manufacturer

Hummingbird Med Devices Inc
  • Source
    DH