Belmont Instrument LLC has recalled approximately 502 Hyperthermia Pump kits, including Procedure Kits and Patient Line Kits, because a connector on the heat exchanger component may be cracked. These cracks can cause fluid to leak while the machine is being prepared for use (priming). No injuries or medical incidents have been reported in relation to this defect.
The cracked connectors lead to fluid leaking from the system. This can cause delays in medical procedures while the equipment is replaced or results in a failure to deliver the intended volume of fluid to the patient.
Consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedure Pack (P/N 902-00048P).
Consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Outflow Patient Line (P/N 902-00039P).
Consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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