NxStage Medical, Inc. recalls NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

Recall date

November 10, 2017

Source

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

Recall number

Z-1132-2018

FDA classification

Class II

Brand / firm

NxStage Medical, Inc.

Sold / distributed

US nationwide distribution

Why it was recalled

Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.

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 PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One