FDA-Device2015-07-01Class II
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Fresenius Medical Care Holdings, Inc.
Hazard
Bacterial contamination.
Sold states
Nationwide Distribution
Affected count
1,856,619 Bottles
Manufactured in
920 Winter St, Waltham, MA, United States
Products
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1827-2015Don't want to check this manually?
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