# FDA recall Z-1707-2019

> **NxStage Medical, Inc.** · Class II · device recall initiated 2019-04-11.

## Product

NxStage PureFlow B Solution, REF RFP-401, M535RPF4010    NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

## Reason for recall

Certain lots were mislabeled with incorrect product number.

## Distribution

US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA

## Key facts

- **Recall number:** Z-1707-2019
- **Recalling firm:** NxStage Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-11
- **Report date:** 2019-06-12
- **Termination date:** 2020-06-08

- **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-1707-2019

## Citation

> AI Analytics. FDA recall Z-1707-2019. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1707-2019. Source: US FDA. Licensed CC0.

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