FDA-Device2015-08-19Class II
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Fresenius Medical Care Holdings, Inc.
Hazard
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
Sold states
Nationwide Distribution
Affected count
2,264,028
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2373-2015Don't want to check this manually?
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