The Recall Desk
ModerateFDA (Devices)·Z-1676-2025·Announced 2025-05-07

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
Category
Medical Device — Hyperthermia / Fluid Delivery
Hazard
Affected units
136

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.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Belmont Instrument LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Belmont Instrument LLC

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