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Recall Observatory FDA recall evidence

Device 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.

Z-0500-2019

October 17, 2018

Class II

Product summary

Firm
NxStage Medical, Inc.
Event
Event 81445
Status
Terminated
Classification
Class II
Quantity
59100
Official record key
device-enforcement:Z-0500-2019

Official wording

Reason: 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

Code information: 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

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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