Belmont Instrument LLC: 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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 208 sets Lot/code info: Model Number: 902-00037. UDI-DI: 00896128002213. Lot Numbers: 20241012, 20241107

UPC codes

00896128002213

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.