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NxStage Medical, Inc. recalls NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Recalled March 28, 2018 · FDA recall Z-1132-2018 · NxStage Medical
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. · FDA Class II
Units
1243400 units
Sold at
US nationwide distribution
Description
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.
Product
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Manufacturer(s)
NxStage Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →