Medical Device Recall: 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
Belmont Instrument LLC · January 2, 2025
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
Product Description
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
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.
States Affected
NATIONWIDE
Quantity Affected
1,029 cases (12,348 sets)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1099-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.