FDA recall Z-2141-2024

Fresenius Medical Care Holdings, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-05-16
Report date
2024-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2141-2024