FDA-Device2016-03-02Class II
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
Sold states
US Distribution to states of: KS, LA, MS, OK, and TX.
Affected count
848 (212 cases)
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0887-2016Don't want to check this manually?
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