Home / Recalls / Medical Devices
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Nu
Recalled July 1, 2015 · FDA recall Z-1827-2015 · Fresenius Medical Care Holdings
Hazard
Bacterial contamination. · FDA Class II
Units
1,856,619 Bottles
Sold at
Nationwide Distribution
Description
Bacterial contamination.
Product
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.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →