FDA-Device2014-10-01Class II
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The 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
Product was held at temperature above the labeled recommended storage temperature
Sold states
Distributed in Texas.
Affected count
72 cases
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The 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-2686-2014Don't want to check this manually?
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