ABG-HM-1 Hummi Micro-Draw Blood Transfer Device 의 안전성 경고

Safety alert

2016-05-27

2016-05-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160527.html

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.