Reported Dec 5, 2018 · Terminated

NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for…

NxStage Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NxStage Medical, Inc. · 350 Merrimack St · Lawrence, MA · 01843-1748

Is this the product you have?

  • NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Lot codes and dates
  • Lot Numbers

    64 of 64 codes

    • F1708230
    • F1708231
    • F1708234
    • F1708235
    • F1708237
    • F1708245
    • F1708246
    • F1708247
    • F1708250
    • F1708251
    • F1708253
    • F1708254
    • F1708256
    • F1709260
    • F1709261
    • F1709267
    • F1710327
    • F1710328
    • F1711343
    • F1711344
    • F1711345
    • Q1711844
    • Q1711853
    • Q1711854
    • Q1711855
    • Q1712025
    • Q1712091
    • Q1712092
    • Q1712137
    • Q1801146
    • Q1801147
    • Q1801148
    • Q1801149
    • Q1801151
    • Q1801202
    • Q1801221
    • Q1801225
    • Q1801226
    • Q1801335
    • Q1801336
    • Q1801337
    • Q1801338
    • Q1801339
    • Q1801340
    • Q1802507
    • Q1802508
    • Q1802509
    • Q1802510
    • Q1802511
    • Q1802512
    • Q1803685
    • Q1803686
    • Q1803687
    • Q1803690
    • Q1803750
    • Q1803754
    • Q1803755
    • Q1803774
    • Q1803775
    • Q1803776
Amount recalled
114777

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 26, 2020 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.