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

Hudson Rci Comfort Flo Humidification System recalled

Teleflex Medical is recalling Hudson Rci Comfort Flo 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 14026704659347 Lot Numbers: 74M1400306 74M1400711 74M1401528 74B1500017 74C1501165 74C1502056 74D1500014 74D1500695 74D1501704 74D1501219 74D1501910 74E1500306 74E1501372 74E1501373 74E1501374 74E1501375 74E1501371 74M1500846 74M1501089 74A1600595 74A1601230 74B1600045 74C1601038 74C1601644 74C1602406 74C1601594 74C1602113 74C1602114 74C1602115 74C1602116 74C1602117 74C1602146 74D1600254 74D1600253 74D1601801 74E1600052 74E1601253 74F1600669 74F1603321 74G1600071 74G1601038 74H1600051 74H1600052 74H1603043 74J1601205 74J1601478 74J1602063 74J1602658 74J1602865 74J1602864 74K1602260 74K1602874 74L1600133 74L1601767 74L1602602 74M1600527 74M1601523 74A1700288 74A1700995 74A1701895 74B1701971 74B1702316 74C1701847 74D1700109 74D1701791 74E1700933 74E1702182 74E1702251 74F1700030 74F1702959 74G1700802 74H1700006 74H1700404 74J1700408 74J1701883 74J1701884 74K1700025 74K1700305 74L1700955 74L1701845 74M1700483 74A1801553 74B1801391 74C1802117 74C1802118 74D1800085 74D1801077 74E1800628 74E1800789 74E1802236 74F1800042 74E1803151 74F1801157 74G1800356 74H1800881 74H1802700 74K1800753 74L1802033 74M1800649 74A1900149 74A1901354 74A1901414 74B1900011 74B1900245 74B1902467 74D1901101 74D1903025

Quantity recalled127293 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-1114-2020
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 Humidification System, REF 2410, humidifier nebulizer kit

Where it was distributed

nationwide

Nationwide

Questions about this recall

Is Hudson Rci Comfort Flo Humidification System recalled?

Yes. Teleflex Medical recalled Hudson Rci Comfort Flo Humidification System on 13 Dec 2019. The recall is Class I and its status is Terminated. Recall number Z-1114-2020.

Why was it recalled?

Which lots are affected?

GTIN 14026704659347 Lot Numbers: 74M1400306 74M1400711 74M1401528 74B1500017 74C1501165 74C1502056 74D1500014 74D1500695 74D1501704 74D1501219 74D1501910 74E1500306 74E1501372 74E1501373 74E1501374 74E1501375 74E1501371 74M1500846 74M1501089 74A1600595 74A1601230 74B1600045 74C1601038 74C1601644 74C1602406 74C1601594 74C1602113 74C1602114 74C1602115 74C1602116 74C1602117 74C1602146 74D1600254 74D1600253 74D1601801 74E1600052 74E1601253 74F1600669 74F1603321 74G1600071 74G1601038 74H1600051 74H1600052 74H1603043 74J1601205 74J1601478 74J1602063 74J1602658 74J1602865 74J1602864 74K1602260 74K1602874 74L1600133 74L1601767 74L1602602 74M1600527 74M1601523 74A1700288 74A1700995 74A1701895 74B1701971 74B1702316 74C1701847 74D1700109 74D1701791 74E1700933 74E1702182 74E1702251 74F1700030 74F1702959 74G1700802 74H1700006 74H1700404 74J1700408 74J1701883 74J1701884 74K1700025 74K1700305 74L1700955 74L1701845 74M1700483 74A1801553 74B1801391 74C1802117 74C1802118 74D1800085 74D1801077 74E1800628 74E1800789 74E1802236 74F1800042 74E1803151 74F1801157 74G1800356 74H1800881 74H1802700 74K1800753 74L1802033 74M1800649 74A1900149 74A1901354 74A1901414 74B1900011 74B1900245 74B1902467 74D1901101 74D1903025

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

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