NxStage PureFlow B Solution recalled over labeling errors
- Recall date
- April 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- NxStage Medical, Inc. recalls NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with ren…
- Recall number
- Z-1706-2019
- FDA classification
- Class II
- Brand / firm
- NxStage Medical, Inc.
- Sold / distributed
- US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
Why it was recalled
Certain lots were mislabeled with incorrect product number.
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, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
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