Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Renal Therapies Group, LLC directly.
Affected Products
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
Quantity: 1060 cases (4240 bottles)
Why Was This Recalled?
The bottles are mislabeled with an incorrect part number.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report