FDAFDA · Food and drugs·Recall number Z-3091-2026
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Published September 9, 2026 · Recall initiated: July 14, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints of blue-green discoloration in product
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Distributor
- Worldwide distribution - US Nationwide and the country of Mexico.
- Lot
- 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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