FDA-Device2014-03-05Class II
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. 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
Mislabeled product.
Sold states
US Distribution including the states of NY, TX, ID, AR, CA and AL
Affected count
969 cases (2 bags per case)
Manufactured in
350 Merrimack Street, Lawrence, MA, United States
Products
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. 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-1073-2014Don't want to check this manually?
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