FDA-Device2026-09-09Class IIPROCESSING DEFECT
Fresenius GRANUFLO Dry Acid Concentrate recalled for blue-green discoloration
What this means
Fresenius Medical Care has recalled certain lots of GRANUFLO Dry Acid Concentrate used in hemodialysis machines after receiving reports of blue-green discoloration in the product. The affected product numbers are 0FD2251-3B and 0FD3251-3B, with specific lot numbers listed by the FDA.
- Check if you use GRANUFLO Dry Acid Concentrate and verify the product number and lot number against the FDA recall notice
- Contact your dialysis provider or Fresenius Medical Care immediately if you have affected product
- Do not use affected lots until you receive guidance from your healthcare provider or the manufacturer
The agency's original wording
Hazard
Complaints of blue-green discoloration in product
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Mexico.
Affected count
27,216 cs; 2,316 ea
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3091-2026More Fresenius Medical Care recalls
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk during dialysis
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk
- FDA-Device2026-09-09Fresenius Citrasate Liquid Acid Concentrate recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius NaturaLyte Liquid Acid Concentrate for Hemodialysis recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius 5008X Standard HD blood tubing set recalled for blood leak risk
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