FDA-Device2020-02-19Class I
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
TELEFLEX MEDICAL INC
Hazard
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.
Sold states
nationwide
Affected count
95696 devices
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1115-2020Don't want to check this manually?
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