Z-0500-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2018
- Initiation Date
- October 17, 2018
- Termination Date
- August 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59100
Product Description
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.
Reason for Recall
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
Distribution Pattern
US Nationwide Distribution.
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