Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
Teleflex Medical is recalling 95,696 Hudson RCI Comfort Flo Humidification Systems due to a potential risk of water flooding the column and entering the patient circuit during high-flow oxygen therapy.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. Per the severity rubric, FDA Class I recalls are assigned a score of 5 (Critical) because they represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Teleflex Medical Inc. is recalling 95,696 units of the Hudson RCI Comfort Flo Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit. The recall is nationwide and affects specific lot numbers listed in the agency's official documentation.
The recall was initiated because there is a 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. This defect could compromise the safety of the medical device when used for respiratory support.
Healthcare providers and consumers should stop using the affected devices immediately and contact Teleflex Medical Inc. for instructions on replacement or return. The recall is classified as FDA Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 95,696
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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Same hazard · water flooding
See all →- CriticalTeleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
FDA (Devices) · 2020-02-19