Belmont Instrument LLC recalls Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operati…

Recall date

January 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1099-2025

FDA classification

Class II

Brand / firm

Belmont Instrument LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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