FDA-Device2014-05-28Class I

Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part 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

Naturalyte Liquid Bicarbonate maybe contaminated

Sold states
Worldwide Distribution - USA (nationwide) and Canada.
Affected count
672,784 units
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part 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-1639-2014

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