# FDA recall Z-1678-2025

> **Belmont Instrument LLC** · Class II · device recall initiated 2025-03-31.

## Product

3.0 Liter Disposable Set (4 sets/case).  Model Number: 903-00032.      The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set.

## Reason for recall

Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.

## Distribution

Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI.  International distribution to Czechia, Italy, Norway.

## Key facts

- **Recall number:** Z-1678-2025
- **Recalling firm:** Belmont Instrument LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-31
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1678-2025

## Citation

> AI Analytics. FDA recall Z-1678-2025. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-1678-2025. Source: US FDA. Licensed CC0.

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