CLASS I Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

Hudson Rci Comfort Flo Corrugated Humidification System recalled

Teleflex Medical is recalling Hudson Rci Comfort Flo Corrugated Humidification System with Remote Temperature Port, distributed nationwide in the US. The recall was initiated on 13 Dec 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 14026704659378 Lot Numbers: 74J1500186 74L1502160 74M1500351 74A1600591 74A1601240 74A1602237 74C1601017 74C1602179 74D1600258 74D1601234 74D1601806 74E1600055 74G1600015 74H1600056 74J1601477 74J1602933 74K1602258 74L1600988 74M1600529 74B1701595 74C1700695 74E1702180 74F1700032 74G1700703 74G1700591 74G1700804 74H1701221 74J1700696 74J1700697 74J1700698 74K1700304 74K1702510 74A1802332 74A1802413 74B1801277 74C1800029 74C1800491 74C1800455 74C1801364 74C1801891 74D1800076 74E1800783 74E1800782 74F1800029 74G1800017 74H1801292 74J1800059 74K1800024 74L1800063 74L1802366 74M1800652 74A1901353 74A1901830 74B1900649 74C1900439 74D1900088 74D1900181

Quantity recalled60467 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1113-2020
FDA event ID: 84588
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class I
Status: Terminated
Recall initiated: 13 Dec 2019
FDA classified: 7 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

13 Dec 2019	Recall initiated by company
7 Feb 2020	Classified by FDA	+56 days
19 Feb 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 14026704659378 Lot Numbers: 74J1500186 74L1502160 74M1500351 74A1600591 74A1601240 74A1602237 74C1601017 74C1602179 74D1600258 74D1601234 74D1601806 74E1600055 74G1600015 74H1600056 74J1601477 74J1602933 74K1602258 74L1600988 74M1600529 74B1701595 74C1700695 74E1702180 74F1700032 74G1700703 74G1700591 74G1700804 74H1701221 74J1700696 74J1700697 74J1700698 74K1700304 74K1702510 74A1802332 74A1802413 74B1801277 74C1800029 74C1800491 74C1800455 74C1801364 74C1801891 74D1800076 74E1800783 74E1800782 74F1800029 74G1800017 74H1801292 74J1800059 74K1800024 74L1800063 74L1802366 74M1800652 74A1901353 74A1901830 74B1900649 74C1900439 74D1900088 74D1900181

Where was it sold?

nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 84588

This product is part of a recall event; the main page for the event is Hudson Rci Comfort Flo Humidification System recalled.

Reported	Class	Recall	Company	Reason	Where
19 Feb 2020	CLASS I	Hudson Rci Comfort Flo Humidification System recalled	Teleflex Medical	Other	Nationwide
19 Feb 2020	CLASS I	Hudson Rci Comfort Flo Corrugated Humidification System recalled	Teleflex Medical	Other	Nationwide
19 Feb 2020	CLASS I	Hudson Rci Comfort Flo Humidification System With Remote recalled	Teleflex Medical	Temperature Abuse	Nationwide

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