# FDA recall Z-1536-2021

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2021-03-18.

## Product

AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies.  Fresenius P/N 24-2500-0    All 3 units make up the AquaBplus 2500Fresenius Part Number:  G02040109-US AquaBplus 3000 - Typ USA  G02040115-US AquaBplus 2500 - Typ USA  G02040120FMC-US AquaBplus HF- Typ USA

## Reason for recall

AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation

## Distribution

US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.

## Key facts

- **Recall number:** Z-1536-2021
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-18
- **Report date:** 2021-05-19
- **Termination date:** 2024-04-10

- **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-1536-2021

## Citation

> AI Analytics. FDA recall Z-1536-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1536-2021. Source: US FDA. Licensed CC0.

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