FDA-Device2022-11-16Class II
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Fresenius Medical Care Holdings, Inc.
Hazard
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
Sold states
Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
Affected count
17700
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0181-2023Don't want to check this manually?
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