FDA-Device2018-03-21Class II
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.
Fresenius Medical Care Renal Therapies Group, LLC
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.
Sold states
US Distribution to states of: CA, FL, KS, LA, and TX.
Affected count
598 cases
Manufactured in
920 Winter St, Waltham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2018Don't want to check this manually?
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