FDA-Device2025-02-12Class II
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
Belmont Instrument LLC
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
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.
Affected count
1,029 cases (12,348 sets)
Manufactured in
780 Boston Rd, Billerica, MA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2025Don't want to check this manually?
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