# FDA recall Z-0098-2021

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2020-09-01.

## Product

AquaBplus and AquaBplus B2 Water Purification System.  For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies.    AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1  AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part  Number: 24-2000-0

## Reason for recall

Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the  products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.

## Distribution

US distribution to DE, NC, OK, PA, and TX.

## Key facts

- **Recall number:** Z-0098-2021
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-01
- **Report date:** 2020-10-21
- **Termination date:** 2021-01-20

- **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-0098-2021

## Citation

> AI Analytics. FDA recall Z-0098-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0098-2021. Source: US FDA. Licensed CC0.

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