Fresenius Medical Care Holdings, Inc.: US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-

Hazard

Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.

Details from the source

Reason for recall: Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply. Distribution: US Nationwide distribution in the states of AL, IN, AK, WI. Quantity: 4 units Lot/code info: UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087

UPC codes

04251285200357

Source

Official record: FDA (Device enforcement) ↗

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