# FDA recall Z-1864-2025

> **NxStage Medical Inc** · Class II · device recall initiated 2025-04-28.

## Product

NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

## Reason for recall

Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1864-2025
- **Recalling firm:** NxStage Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-28
- **Report date:** 2025-06-04

- **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-1864-2025

## Citation

> AI Analytics. FDA recall Z-1864-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1864-2025. Source: US FDA. Licensed CC0.

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