FDANovember 10, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

nxstage medicalnxstage

UPCs

0084228910125800842289101265

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One — Recall Details · AllClear