Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Recalled by TELEFLEX MEDICAL INC Due to There is the potential for water to flood...

Date: December 13, 2019
Company: TELEFLEX MEDICAL INC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact TELEFLEX MEDICAL INC directly.

Affected Products

HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit

Quantity: 60467 devices

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About TELEFLEX MEDICAL INC

TELEFLEX MEDICAL INC has 32 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report