NxStage MDS Corporation recalls NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and rep…

Recall date

January 29, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1191-2024

FDA classification

Class II

Brand / firm

NxStage MDS Corporation

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.