FDA-Device2026-09-09Class IIPROCESSING DEFECT
Fresenius Citrasate Liquid Acid Concentrate recalled for blue-green discoloration
What this means
Fresenius Medical Care has recalled specific lots of Citrasate Liquid Acid Concentrate used in hemodialysis due to blue-green discoloration observed in the product. The discoloration may indicate a quality issue that could affect the product's safety or efficacy. No injuries have been reported.
- Check if your facility uses Citrasate with product numbers 08-2251-CA, 08-3251-CA, or 13-2251-CA and lot numbers 26BXAC038, 26BXAC039, 26BXAC040, or 26BXAC041.
- Do not use product showing blue-green discoloration.
- Contact Fresenius Medical Care for instructions on product return or replacement.
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
56,036 cs; 1,788 drums; 204 ea
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3093-2026More 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 NaturaLyte Liquid Acid Concentrate for Hemodialysis 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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