Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2141-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 16, 2024

Date Posted: June 19, 2024

Recall Number: Z-2141-2024

Event ID: 94676

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.

Status: Ongoing

Product Quantity: 4 units

Code Information:

UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087

Distribution Pattern:

US Nationwide distribution in the states of AL, IN, AK, WI.

Voluntary or Mandated:

Voluntary: Firm initiated