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Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated t
Recalled March 21, 2018 · FDA recall Z-1010-2018 · Fresenius Medical Care Renal Therapies Group
Hazard
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L. · FDA Class II
Units
598 cases
Sold at
US Distribution to states of: CA, FL, KS, LA, and TX.
Description
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Product
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle 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.
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →