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Recall Observatory FDA recall evidence

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

January 02, 2025

Class II

Product summary

Firm
Belmont Instrument LLC
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

    reason.no_named_rule · v1.0.0

    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