# FDA recall Z-1191-2024

> **NxStage MDS Corporation** · Class II · device recall initiated 2024-01-29.

## Product

NxStage Cartridge Express with Speedswap, Catalog No. CAR-535.    An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.

## Reason for recall

Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.

## Distribution

US domestic distribution to Dialysis Centers located in AZ, CA, CO, GA, IL, IN, MA, MD, MI, MN, MO, MS, NC, NJ, NY, TN, TX, VA, WI. No international distribution.

## Key facts

- **Recall number:** Z-1191-2024
- **Recalling firm:** NxStage MDS Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-29
- **Report date:** 2024-03-06

- **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-1191-2024

## Citation

> AI Analytics. FDA recall Z-1191-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1191-2024. Source: US FDA. Licensed CC0.

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