Drug recall
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA…
FDA recall event 99543 · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Event ID | 99543 |
|---|---|
| Recall numbers | Z-3091-2026, Z-3092-2026, Z-3093-2026 |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Product type | Devices |
| Products | Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis, GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis, NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints of blue-green discoloration in product |
| Initiation date | Jul 14, 2026 |
| Report date | Sep 9, 2026 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: