Belmont Instrument recalls sterile patient line kits (model 902-00037) due to risk of fluid leaks from cracks in the heat exchanger connector during use. Affected units include specific lot numbers and dates.
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Belmont Instrument is recalling their Straight Inflow/Outflow Patient Line Kit (model 902-00037) because a crack in the female connector on the heat exchanger could cause fluid leaks during priming. This poses a risk of infection or contamination if the leak occurs while the device is in use.
The female quick connector on the heat exchanger set may crack, leading to fluid leaks during the priming process of the rapid infuser. This could cause contamination or infection if the leak occurs while the device is in use.
Healthcare professionals using the Straight Inflow/Outflow Patient Line Kit with the Hyperthermia Pump are most at risk. Patients receiving treatment with this kit could be affected if the leak occurs.
Check for model number 902-00037 on the kit. Affected units were shipped with lot numbers 20241012 and 20241107. The kit includes a 4.4 Liter Reservoir, Heat Exchanger set, and Straight Inflow/Outflow Patient Line.
Inspect the female quick connector on the Heat Exchanger set (model 902-00006P) for cracks before use.
Reach out to Belmont Instrument LLC for guidance on whether the kit is affected and what to do next.
The recall does not specify that the kit is safe if no cracks are visible. The hazard is potential cracking during use, so it's recommended to check for cracks before use.
The recall does not provide specific action steps beyond checking for cracks and contacting the manufacturer. Affected units may need to be discarded or returned.
Lot numbers 20241012 and 20241107 are affected.
We’ve drafted a message you can send Belmont Instrument to request your refund or repair — edit it as you like.
Subject: Recall Z-1675-2025 — Belmont Instrument Belmont Instrument Hello, I own a Belmont Instrument that is covered by recall Z-1675-2025 from Belmont Instrument. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
