Belmont Hyperthermia Pump Line Kit Heat Exchanger Connector Crack Recall
Belmont Instrument is recalling the Straight Inflow/Bifurcated Outflow Line Kit (Model 902-00038) due to potential cracks in the female connector on the Heat Exchanger set, which may cause fluid leaks during priming.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall. The source text does not report any illness, injury, or hospitalization. The hazard is a manufacturing defect (cracked connector) that creates a theoretical risk of fluid leakage, making this a precautionary recall without known adverse events reported.
Plain-English summary
Belmont Instrument LLC is recalling the Straight Inflow/Bifurcated Outflow Line Kit, Model Number 902-00038, a sterile, single-use, disposable set used with the Hyperthermia Pump. The kit consists of a 4.4 Liter Reservoir, Heat Exchanger set, and Straight Inflow/Bifurcated Outflow Patient Line, with all three components packaged separately and connected prior to use.
The recall is due to a potential crack in the female quick connector located on the Heat Exchanger set (Part Number 902-00006P). This crack can lead to fluid leaks through the connector during priming of the rapid infuser.
A total of 136 sets have been distributed nationwide across the United States, as well as internationally to Canada, Hungary, South Korea, Latvia, and Malaysia. The affected lot is Lot Number 20241013 (UDI-DI: 00896128002220).
Customers who have received this product should contact Belmont Instrument LLC for guidance on managing affected units and obtaining replacements or repairs.
The recalled product
- Product
- Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N
- 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 (1)
- Model Number: 902-00038. UDI-DI: 00896128002220. Lot Number: 20241013
Distribution
Distributed nationwide across the United States.
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