The Recall Desk
HighFDA (Devices)·Z-1675-2025·Announced 2025-05-07

Belmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack

Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit (Model 902-00037) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leaks during use.

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: This is an FDA Class II recall of a medical device with a risk of harm (fluid leakage during patient treatment). The source text does not report any illnesses or injuries, and the hazard is potential rather than confirmed, which aligns with the rubric criterion for High (3): "risk-of-harm products where injury has not yet been reported."

Plain-English summary

Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit, Model Number 902-00037, 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/Outflow Patient Line, packaged separately and connected prior to use.

The recall affects 208 sets with Model Number 902-00037, UDI-DI 00896128002213, and Lot Numbers 20241012 and 20241107. The issue is a potential crack in the female connector located on the Heat Exchanger set, which will lead to fluid leakage through the crack during priming of the rapid infuser.

Distribution includes US nationwide in AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, and Malaysia.

Healthcare facilities and users should cease use of affected kits and contact Belmont Instrument LLC for instructions on return or replacement.

The recalled product

Product
Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902
Manufacturer
Belmont Instrument LLC
Category
Medical Device — Infusion / Hyperthermia Equipment
Hazard
Affected units
208

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 (2)

  • Model Number: 902-00037. UDI-DI: 00896128002213. Lot Numbers: 20241012
  • 20241107

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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