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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy."
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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