Recall Z-1191-2024— NxStage MDS Corporation
Class II · Ongoing
Class II FDA medical device recall by NxStage MDS Corporation, initiated 2024-01-29. It names one FDA 510(k) clearance: K183158. 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..
- Recalling firm
- NxStage MDS Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-29
- Firm location
- Lawrence, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.