NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for…
- Recall date
- October 17, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0500-2019
- FDA classification
- Class II
- Brand / firm
- NxStage Medical, Inc.
- Sold / distributed
- US Nationwide Distribution.
Why it was recalled
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
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-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
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