Recall Z-3091-2026 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Renal Therapies Group, LLC
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
| Date | Sep 3, 2026 (initiated Jul 14, 2026) |
| Status | Open, Classified |
| Reason | Complaints of blue-green discoloration in product |
| Root cause | Material/Component Contamination |
| Action | 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 Inform |
| Quantity | 27,216 cs; 2,316 ea |
| Distribution | Worldwide distribution - US Nationwide and the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC, May 8, 2020 |