Class II
Medical Device Recall: 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-1
Fresenius Medical Care Holdings, Inc. · May 16, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
4 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2141-2024
Status: ongoing
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