FDA recall Z-1114-2020

Product

HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit

Reason for recall

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.

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2019-12-13

Report date

2020-02-19

Termination date

2024-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2020