Events

Alerta De Seguridad para ABG-HM-1 Hummi Micro-Draw Blood Transfer Device

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Hummingbird Med Devices Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-05-27
  • Fecha de publicación del evento
    2016-05-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160527.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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