FDA Device recall Z-1099-2025
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or al…
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or al… by Belmont Instrument, citing 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 ne….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1099-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-02 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Belmont Instrument |
| Distribution | US |
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
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
Identifiers
| code_info | UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1099-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.