FDA-Device2013-05-08Class II

NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical, Inc.
Hazard

Product may be mislabeled.

Sold states
Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
Affected count
1480 cases (2 bags per case)
Manufactured in
350 Merrimack Street, Lawrence, MA, United States
Products
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The 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-1214-2013

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