# FDA recall Z-1675-2025

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

## Product

Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037.      Sterile, single-use, disposable set used with the Hyperthermia Pump.  The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Outflow Patient Line (P/N 902-00039P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).

## Reason for recall

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.

## Key facts

- **Recall number:** Z-1675-2025
- **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-1675-2025

## Citation

> AI Analytics. FDA recall Z-1675-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1675-2025. Source: US FDA. Licensed CC0.

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