A Class I recall is underway for Teleflex Medical’s Comfort Flo Humidification Systems. According to the FDA, there is a risk for water to flood the column and enter the circuit in the system, then enter the nose and lungs of the patient.
The FDA reported zero deaths, 102 complaints, and 8 injuries related to the device, including oxygen desaturation and bradycardia. The agency warned that use of the affected devices may cause serious adverse health consequences, including oxygen desaturation and the need for further treatment to prevent long-term or serious injury.
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.
|Name and Version||Product Code|
|Comfort Flo Humidification System, REF 2410, Humidifier Nebulizer Kit||GTIN 14026704659347|
|Comfort Flo Humidification System with Remote Temperature Port, REF 2414, Humidifier Nebulizer Kit||GTIN 14026704659354|
|Comfort Flo Corrugated Humidification System, REF 2415, Humidifier Nebulizer Kit||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 US: 398,320
- Date Initiated by Firm: December 13, 2019
Healthcare providers with effected stock are urged to not use the products and quarantine them, identify all patients that are currently exposed to use of the product, then complete a Recall Acknowledge Form and return to [email protected].