# FDA recall Z-1099-2025

> **Belmont Instrument LLC** · Class II · device recall initiated 2025-01-02.

## Product

Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion.    Part Number:903-00006

## Reason for recall

Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China,  Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.

## Key facts

- **Recall number:** Z-1099-2025
- **Recalling firm:** Belmont Instrument LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-02
- **Report date:** 2025-02-12

- **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-1099-2025

## Citation

> AI Analytics. FDA recall Z-1099-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1099-2025. Source: US FDA. Licensed CC0.

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