Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid… — Class II medical device recall Z-1099-2025
Ongoing recall by Belmont Instrument LLC, reported 2025-02-12, distributed nationwide. Disposable set may leak during priming from a female quick connector due to a crack in the female quick connec
| Recall number | Z-1099-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Belmont Instrument LLC, Billerica, MA, United States |
| Recall initiated | 2025-01-02 |
| Classified | 2025-02-04 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, JP, MY, PL, TW, UA |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00896128002022 |
| Lot numbers | 20240910, 20241002, 20241006, 20241014 |
| Model numbers | 903-00006 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1099-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.