Device recall
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
- Recall number
- Z-3091-2026
- Event id
- 99543
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Report date
- Sep 9, 2026
- Posted
- Sep 3, 2026
- Initiated
- Jul 14, 2026
- Center classification date
- Sep 3, 2026
- Product code
- KPO
- Device type
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Reason
- Complaints of blue-green discoloration in product
- Root cause
- Material/Component Contamination
- Quantity
- 27,216 cs; 2,316 ea
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of Mexico.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K192209
- Location
- Waltham, MA, United States