FDAFDA · Food and drugs·Recall number Z-0502-2019
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Published December 5, 2018 · Recall initiated: October 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NxStage Medical, Inc.
- Distributor
- US Nationwide Distribution.
- Lot
- Lot Numbers: F1708255, F1709285, F1710323, Q1711861, Q1711863, Q1712021, Q1712022, Q1712023, Q1712033, Q1801345, Q1802399, Q1802400
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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