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, 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 14026704659361 Lot Numbers: 74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071

Quantity recalled30566 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-1112-2020
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: Other Reasons
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.

Product as listed by the FDA

HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit

Where it was distributed

nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 14026704659361 Lot Numbers: 74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071

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 Humidification System With Remote recalled	Teleflex Medical	Temperature Abuse	Nationwide
19 Feb 2020	CLASS I	Hudson Rci Comfort Flo Corrugated Humidification System recalled	Teleflex Medical	Temperature Abuse	Nationwide

More recalls from Teleflex Medical

All 235

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022Device	CLASS II	Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
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23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled	Teleflex Medical	Other	Nationwide

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