# FDA recall Z-2141-2024

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2024-05-16.

## 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

- **Recall number:** Z-2141-2024
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-16
- **Report date:** 2024-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2141-2024. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-2141-2024. Source: US FDA. Licensed CC0.

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