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Open, Classified

GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

FDA Recall Z-3091-2026 · Posted 2026-09-03

Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2026-07-14
Product Quantity27,216 cs; 2,316 ea

Reason for Recall

Complaints of blue-green discoloration in product

Firm 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 Information and Education Office at 1-855-616-2309.

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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