medical Class II Updated 2021-01-20

Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-

Recalled Product

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Hazard / Issue

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 20LXAC056 20LXAC057 20NXAC038 20LXAC041 20LXAC055 Additional affected lots as of 3/17/21: 20NXAC013 20NXAC035
View official government recall

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