FDA Class I Recall: Teleflex Medical Comfort Flo Humidification

Feb. 20, 2020

Teleflex Medical is recalling its Comfort Flo Humidification Systems due to the risk for water to flood the column and enter the circuit in the system. If water enters the circuit, water can enter the nose and lungs of the patient.

The use of affected product may cause serious adverse health consequences, including low oxygen in the blood (desaturation) and the need for further treatment to prevent long term or serious injury.

There have been 102 complaints and 8 injuries with this device, including low oxygen in the blood (desaturation) and a slower than normal heart rate (bradycardia). There have been no reported deaths.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The products are the COMFORT FLO Humidification System, REF 2410, Humidifier Nebulizer Kit, Product Code - GTIN 14026704659347; COMFORT FLO Humidification System with Remote Temperature Port, REF 2414, Humidifier Nebulizer Kit, Product Code- GTIN 14026704659354; COMFORT FLO Corrugated Humidification System, REF 2415, Humidifier Nebulizer Kit, Product Code - GTIN 14026704659361; Corrugated COMFORT FLO Remote Temperature Port, REF 2416, Humidifier Nebulizer Kit, GTIN -14026704659378, Model or Catalog Numbers: 2410; 2414; 2415; 2416.

Manufacturing Dates: October 1, 2014 to June 30, 2019, Distribution Dates: October 1, 2014 to October 31, 2019

Devices Recalled in the U.S.: 398,320

The Comfort Flo Humidification System is used to provide a constant flow of heated and humidified breathing gases to patients. It can be used by neonatal, pediatric and adult patients in health care settings. The system is used with the Neptune Heated Humidifier with ConchaSmart Technology and ConchaTherm Neptune Heated Humidifier.

FDA has the announcement