FDAFDA · Food and drugs·Recall number Z-1073-2014
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Published March 5, 2014 · Recall initiated: January 24, 2014
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
Mislabeled product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NxStage Medical, Inc.
- Distributor
- US Distribution including the states of NY, TX, ID, AR, CA and AL
- Lot
- Lot Number: F113662
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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