FDA Device recall Z-3091-2026
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B by Fresenius Medical Care Renal Therapies Group, citing complaints of blue-green discoloration in product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3091-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-14 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Reason
Complaints of blue-green discoloration in product
Identifiers
| code_info | 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-…1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
Other recalls by Fresenius Medical Care Renal Therapies Group
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FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3091-2026%22
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