Reported Feb 12, 2025 · Ongoing

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

Belmont Instrument LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Belmont Instrument LLC · 780 Boston Rd · Billerica, MA · 01821-5925

Is this the product you have?

  • 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 Number903-00006
Lot codes and dates
  • UDI-DI00896128002022
  • Lot Numbers
    • 20240910
    • 20241002
    • 20241006
    • 20241014
Amount recalled
1,029 cases (12,348 sets)

Where it was sold

  • Nationwide

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

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