Z-1099-2025 Class II Ongoing
FDA device recall Z-1099-2025 was initiated by Belmont Instrument LLC on January 2, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 1,029 cases (12,348 sets).
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- January 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,029 cases (12,348 sets)
Product Description
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
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 Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.
Code Information
UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014