Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
Teleflex Medical is recalling 127,293 Hudson RCI Comfort Flo Humidification Systems nationwide due to a potential risk of water flooding the column and entering the 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'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Plain-English summary
Teleflex Medical Inc. is recalling 127,293 units of the Hudson RCI Comfort Flo Humidification System, Reference 2410, humidifier nebulizer kit. The devices were distributed nationwide. The recall involves specific lot numbers listed in the agency's structured product information.
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 condition could compromise the integrity of the oxygen delivery system.
Healthcare facilities and consumers who have these devices should stop using them and contact Teleflex Medical Inc. for instructions on how to return the product or obtain a replacement. The FDA has classified this as a Class I recall, 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, REF 2410, humidifier nebulizer kit
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 127,293
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