FDA Medical devices recall ·
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser… recall
- Recall number
- Z-1099-2025
- Date
- (initiated January 2, 2025)
- Company / brand
- Belmont Instrument LLC
780 Boston Rd, Billerica, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,029 cases (12,348 sets)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1099-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.