Recall Z-3091-2026
Fresenius Medical Care Renal Therapies Group, LLC · initiated July 14, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Codes / lots: 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
Reason for recall
Complaints of blue-green discoloration in product
FDA-determined cause: Material/Component Contamination
Action taken
Fresenius Medical Care issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/15/2026 via USPS first class mail. The notice explained the issue, potential risk and requested the following action: "1. Identify if you have any affected product lots on hand. 2. IMMEDIATELY segregate and discontinue use of affected lots. 3. Contact FMCRTG (1-833-203-5448) between 8:00 AM 8:00 PM Eastern daily, for return of affected lots and replacement of your stock. 4. Complete and return the attached REPLY FORM." For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Details
- Recall number
- Z-3091-2026
- Initiated
- July 14, 2026
- Posted by FDA
- September 3, 2026
- Product code
- KPO – Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Quantity
- 27,216 cs; 2,316 ea
- Distribution
- Worldwide distribution - US Nationwide and the country of Mexico.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3092-2026 Class II | NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers:…Complaints of blue-green discoloration in product | 07/14/2026Open, Classified |
| Z-3093-2026 Class II | Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers:…Complaints of blue-green discoloration in product | 07/14/2026Open, Classified |