# FDA recall Z-1132-2018

> **NxStage Medical, Inc.** · Class II · device recall initiated 2017-11-10.

## Product

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

## Reason for recall

Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk.  The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.

## Distribution

US nationwide distribution

## Key facts

- **Recall number:** Z-1132-2018
- **Recalling firm:** NxStage Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-10
- **Report date:** 2018-03-28
- **Termination date:** 2019-12-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2018

## Citation

> AI Analytics. FDA recall Z-1132-2018. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1132-2018. Source: US FDA. Licensed CC0.

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