HUDSON RCI COMFORT FLO Humidification System — Class I medical device recall Z-1114-2020
Terminated recall by TELEFLEX MEDICAL INC, reported 2020-02-19, distributed nationwide. There is the potential for water to flood the column and enter the circuit under circumstances where an abnorm
| Recall number | Z-1114-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX MEDICAL INC, Morrisville, NC, United States |
| Recall initiated | 2019-12-13 |
| Classified | 2020-02-07 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 127,293 devices |
| UPC / GTIN / UDI-DI | 14026704659347 |
| Lot numbers | 74A1600595, 74A1601230, 74A1700288, 74A1700995, 74A1701895, 74A1801553, 74A1900149, 74A1901354, 74A1901414, 74B1500017, 74B1600045, 74B1701971, 74B1702316, 74B1801391, 74B1900011, 74B1900245, 74B1902467, 74C1501165, 74C1502056, 74C1601038, 74C1601594, 74C1601644, 74C1602113, 74C1602114, 74C1602115, 74C1602116, 74C1602117, 74C1602146, 74C1602406, 74C1701847, 74C1802117, 74C1802118, 74D1500014, 74D1500695, 74D1501219, 74D1501704, 74D1501910, 74D1600253, 74D1600254, 74D1601801 and 67 more |
| Model numbers | 2410 |
Product
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1114-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.