NxStage Cartridge Express with Speedswap — Class II medical device recall Z-1191-2024
Ongoing recall by NxStage MDS Corporation, reported 2024-03-06, distributed in AZ, CA, CO, GA, IL, IN, MA, MD…. Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If thi
| Recall number | Z-1191-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage MDS Corporation, Lawrence, MA, United States |
| Recall initiated | 2024-01-29 |
| Classified | 2024-02-27 |
| Reported by FDA | 2024-03-06 |
| Distributed | AZ, CA, CO, GA, IL, IN, MA, MD, MI, MN, MO, MS, NC, NJ, NY, TN, TX, VA, WI |
| Quantity | 693 |
| Reason classes | packaging |
| Lot numbers | 20878001, 30978013, 30978032, 31178011, 31178019 |
| Model numbers | CAR-535 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1191-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.