Class IIDeviceOngoing

Fresenius Medical Care Renal Therapies Group, LLC

GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

Reason for recall

Complaints of blue-green discoloration in product

Details

Recall number: Z-3091-2026
Event ID: 99543
Recall initiated: Jul 14, 2026
Classified: Sep 3, 2026
Reported: Sep 9, 2026
Quantity: 27,216 cs; 2,316 ea
Distribution: Worldwide distribution - US Nationwide and the country of Mexico.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Waltham, MA, United States
Lot / code info: 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.