Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operatio
Summary
The FDA issued a Class II for Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. by Belmont Instrument LLC. 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 tr.
Details
Source
Device Recall
External ID
Z-1099-2025
Action Date
2025-02-12
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014
Quantity Affected: 1,029 cases (12,348 sets)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-02
Company
Billerica, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Belmont Instrument LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Belmont Instrument LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Belmont Instrument LLC have FDA actions?
Belmont Instrument LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1099-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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