FDA-Device2019-06-12Class II
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.
NxStage Medical, Inc.
Hazard
Certain lots were mislabeled with incorrect product number.
Sold states
US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
Affected count
1998 units
Manufactured in
350 Merrimack St, Lawrence, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1706-2019Don't want to check this manually?
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