Reported Jun 12, 2019 · Terminated
NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with…
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, 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.
- Lot codes and dates
- Lot NumberQ1811792
- Exp Date11/1/2020
- Amount recalled
- 1998 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Certain lots were mislabeled with incorrect product number.
This product could cause temporary or reversible health problems — stop using it.
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