The FDA issued an update on Teleflex’s recall of its Comfort Flo humidification system, which was initiated over the risk of water flooding in the device that could enter the nose and lungs, labeling it a Class I recall.
The recall, initiated on Dec. 13, 2019, spans multiple models of the system, which is used in healthcare settings for neonatal, pediatric and adult patients. It was initiated due to reports of water flooding into the system’s circuit. The water could enter a patient’s nose and lungs and lead to serious health risks.
The agency said there have been 102 complaints and eight injury reports for the device, including low oxygen in the blood and a slower than normal heart rate. No deaths have been reported.