# FDA recall Z-1114-2020

> **TELEFLEX MEDICAL INC** · Class I · device recall initiated 2019-12-13.

## 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.

## Distribution

nationwide

## Key facts

- **Recall number:** Z-1114-2020
- **Recalling firm:** TELEFLEX MEDICAL INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-13
- **Report date:** 2020-02-19
- **Termination date:** 2024-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2020

## Citation

> AI Analytics. FDA recall Z-1114-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1114-2020. Source: US FDA. Licensed CC0.

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