Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
Teleflex Medical is recalling 60,467 Hudson RCI Comfort Flo Corrugated Humidification Systems because water may flood the column and enter the circuit during high-flow oxygen therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for harm (water entering the circuit) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Teleflex Medical Inc. is recalling 60,467 units of the Hudson RCI Comfort Flo Corrugated Humidification System with Remote Temperature Port (REF 2416). The affected devices were distributed nationwide.
The recall is due to a potential safety hazard where water may flood the column and enter the circuit. This risk exists under circumstances where an abnormal pressure differential is created between the water bottle and the column during high-flow oxygen therapy.
Consumers and healthcare providers should stop using the affected devices immediately. Users should contact Teleflex Medical Inc. for further instructions on how to return or replace the product.
The recalled product
- Product
- HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 60,467
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by TELEFLEX MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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