Recall Z-3091-2026— Fresenius Medical Care Renal Therapies Group, LLC
Class II · Ongoing
Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2026-07-14. It names one FDA 510(k) clearance: K192209. 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.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-14
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Reason for recall
Complaints of blue-green discoloration in product
Data sourced from openFDA. This site is unofficial and independent of the FDA.