medical Class II Updated 2018-12-05

NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for

Recalled Product

NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.


Hazard / Issue

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: F1710314, Q1712034, Q1801223, Q1801224, Q1801344, Q1802451, Q1803684, Q1803817, Q1804904
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