Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate drums, Model Number 13-12
Recalled Product
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - 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
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