FDAJanuary 2, 2025device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
belmont instrumentbelmont
UPCs
00896128002022
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
- FDAeTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-1592026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-1492026-03-02
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