Belmont Instrument LLC: 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

Hazard

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

Details from the source

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 Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine. Quantity: 1,029 cases (12,348 sets) Lot/code info: UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014

UPC codes

00896128002022

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.