The MAQUET Servo Humidifier 163, distributed by Teleflex Medical of Durham, NC, is a heat and moisture condenser that is placed over a surgically-created opening in the throat (tracheotomy) or a tube inserted into the trachea to warm and moisten gases breathed in by a patient. The primary users of this device are nurses and respiratory therapists.
It was manufactured in Ireland from September 2012 through September 2013 and distributed in Florida, Kansas, Michigan, and West Virginia from June 2013 through November 2014. There are 100 recalled devices in total with Model # 01-06-8125-8 and catalog # XKC01-06-8125-8.
Cracks were found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified. These cracks may cause oxygen and other gases to leak from the ventilator and prevent the device from delivering sufficient support to the patient. This may potentially cause serious injury or death.
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 Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe