The Recall Desk

FDA (Devices) recall action 82693

NxStage Medical, Inc. recalled 2 products on 2019-06-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-06-12
Critical
0
Units
5,938

Why these products were recalled

Certain lots were mislabeled with incorrect product number.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling specific lots of PureFlow B Solution because they were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Distribution
    14 states
  • ModerateFDA (Devices)··2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling 1,998 units of PureFlow B Solution because certain lots were mislabeled with the incorrect product number.

    Product
    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.
    Category
    Distribution
    14 states