FDA Enforcement
Class II
Ongoing
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
Recall: Z-1099-2025
·
Reported February 12, 2025
Enforcement
- Recall Number
- Z-1099-2025
- Event ID
- 96092
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Belmont Instrument LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- February 12, 2025
- Initiation Date
- January 2, 2025
- Classification Date
- February 4, 2025
- Address
- 780 Boston Rd, Billerica, MA, 01821-5925, United States
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
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 Info
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.
Quantity
1,029 cases (12,348 sets)