On May 26, 2016, Hummingbird Med Devices Inc. recalled 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 on an infant. This could lead to blood or fluid leakage. Blood or fluid loss may result in serious adverse health consequences, including death of the infant.
The Hummi Micro-Draw Blood Transfer Device is a blood collection device with a Y-shaped connector attached to a yellow cannula hub (tube). It connects to a catheter to collect small volume blood samples from infants, including premature infants. The collected blood is transferred from the device to a syringe or other container for transport and processing. The device is primarily used in hospitals.
This recall includes ABG-HM-1 Hummi Micro-Draw Blood Transfer Device with lot numbers 15180, 15286, 15287, 15300 and 15305. There are 37,750 units in California, Kentucky, Maryland and Illinois.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks
See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability