Events

Safety Alert for ABG-HM-1 Hummi Micro-Draw Blood Transfer Device

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hummingbird Med Devices Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-05-27
  • Event Date Posted
    2016-05-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160527.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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