FDA-Device2026-09-09Class IIPROCESSING DEFECT
Fresenius NaturaLyte Liquid Acid Concentrate for Hemodialysis recalled for blue-green discoloration
What this means
Fresenius Medical Care is recalling specific lots of NaturaLyte Liquid Acid Concentrate used in bicarbonate hemodialysis due to reports of blue-green discoloration in the product. The affected lots were distributed nationwide in the U.S. and in Mexico.
- Check if you have one of the affected product numbers and lot numbers listed in this recall
- Do not use the product if it shows blue-green discoloration
- Contact Fresenius Medical Care or your dialysis center for instructions on replacement or disposal
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
2,998 cs; 68 ea
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
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 Bicarbonate Hemodialysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3092-2026More 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 GRANUFLO Dry Acid Concentrate recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius 5008X Standard HD blood tubing set recalled for blood leak risk
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