FDA Device recall Z-1191-2024
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of NxStage Cartridge Express with Speedswap, Catalog No. CAR-535 by Nxstage Mds, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1191-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-29 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nxstage Mds |
| Distribution | AZ, CA, CO, GA, IL, IN, MA, MD, MI, MN, MO, MS, NC, NJ, NY, TN, TX, VA, WI |
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
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.
Identifiers
| code_info | UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1191-2024%22
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