Belmont Instrument LLC recalls Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermi…

Recall date

March 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1674-2025

FDA classification

Class II

Brand / firm

Belmont Instrument LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of 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, Malaysia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).