# FDA recall Z-0811-2018

> **NxStage Medical, Inc.** · Class II · device recall initiated 2018-01-29.

## Product

NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070    Hemodialysis systems and accessories

## Reason for recall

May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare  product.

## Distribution

Worldwide Distribution - USA (nationwide) and to the countries of :  United Kingdom & Spain

## Key facts

- **Recall number:** Z-0811-2018
- **Recalling firm:** NxStage Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-29
- **Report date:** 2018-03-07
- **Termination date:** 2020-04-03

- **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-0811-2018

## Citation

> AI Analytics. FDA recall Z-0811-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0811-2018. Source: US FDA. Licensed CC0.

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