Reported Feb 19, 2020 · Terminated

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

Teleflex Medical Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: TELEFLEX MEDICAL INC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437

Is this the product you have?

  • HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
Lot codes and dates
  • 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
Amount recalled
60467 devices

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 30, 2024 · Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.