Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Nu…
- Recall date
- May 20, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1827-2015
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Holdings, Inc.
- Sold / distributed
- Nationwide Distribution
Why it was recalled
Bacterial contamination.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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