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Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius R
Recalled January 20, 2021 · FDA recall Z-0820-2021 · Fresenius Medical Care Holdings
Hazard
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. · FDA Class II
Units
19646 cases
Sold at
US Nationwide distribution.
Description
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Product
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →