FDA-Device2018-03-28Class II
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
NxStage Medical, Inc.
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.
Sold states
US nationwide distribution
Affected count
1243400 units
Manufactured in
350 Merrimack Street, N/A, Lawrence, MA, United States
Products
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2018Don't want to check this manually?
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