medical Class II Updated 2025-05-07

Belmont Instrument LLC recalls Hyperthermia Pump Procedure Kit. Model Number: 902-00045.

Recalled Product

Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) 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). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 902-00045. UDI-DI: 00896128002589. Lot Numbers: 20241005, 20241108
View official government recall

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