medical Class II Updated 2021-01-20

Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate drums, Model Number 13-22

Recalled Product

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - 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: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018
View official government recall

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