Device 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
Z-1099-2025
Product summary
- Event
- Event 96092
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,029 cases (12,348 sets)
- Official record key
device-enforcement:Z-1099-2025
Official wording
Reason: 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
Code information: UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.
Derived failure modes
-
Unknown
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