FDAFDA · Food and drugs·Recall number Z-0684-2013
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Published January 23, 2013 · Recall initiated: November 26, 2012
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
GranuFlo Dry Acid Concentrate may show discoloration
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- US Nationwide Distribution
- Lot
- Lot Number:12PXGF002
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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