medical Class II Updated 2018-12-05

NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for

Recalled Product

NxStage PureFlow B Solution-RFP-400, 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: F1709268, F1709269, F1709276, F1709277, F1710321, F1711329, F1711334, F1711339, F1711340, F1711341, F1711342, Q1711804, Q1711805, Q1711806, Q1711807, Q1711846, Q1711847, Q1711848, Q1711849, Q1711850, Q1711851, Q1711856, Q1711857, Q1711862, Q1712958, Q1712964, Q1803629, Q1803630, Q1803688, Q1803689, Q1803757, Q1803830, Q1803831, Q1803832

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