# FDA recall Z-2376-2021

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2021-08-06.

## Product

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

## Reason for recall

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

## Distribution

US Nationwide Distribution and PR    OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa

## Key facts

- **Recall number:** Z-2376-2021
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-06
- **Report date:** 2021-09-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2021

## Citation

> AI Analytics. FDA recall Z-2376-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2376-2021. Source: US FDA. Licensed CC0.

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