Belmont Medical 3-Spike Disposable Set May Leak During Use
The Belmont Medical 3-Spike Disposable Set may leak during priming due to a crack in its female quick connector, potentially delaying warmed infusions in hospital settings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device that is a risk-of-harm product used in critical patient care. The defect may cause treatment delays. No illnesses or injuries have been reported.
Plain-English summary
The Belmont Medical 3-Spike Disposable Set (Part Number 903-00006) is used with the Belmont Rapid Infuser RI-2 to deliver warmed blood and fluids to patients in hospitals and alternate care facilities.
The disposable set may leak during priming due to a crack in the female quick connector. When this occurs, the set must be replaced, which may delay treatment.
The recall affects 1,029 cases containing 12,348 total sets distributed nationwide in the United States and to Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan, and Ukraine. The affected lot numbers are 20240910, 20241002, 20241006, and 20241014.
Healthcare facilities should verify the lot numbers of sets in their inventory. Sets with visible cracks should not be used. Facilities with affected sets should contact Belmont Instrument LLC or the FDA.
The recalled product
- 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
- Manufacturer
- Belmont Instrument LLC
- Hazard
- connector-crack
- fluid-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 00896128002022 Lot Numbers: 20240910
- 20241002
- 20241006
- 20241014
Distribution
Distributed nationwide across the United States.
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