medical Class II Updated 2018-06-13

Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis

Recalled Product

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.

Hazard / Issue

The bottles are mislabeled with an incorrect part number.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: 18CXAC095
View official government recall

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