Medical device recalls Moderate risk

Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Co…

Recall date
July 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2373-2015
FDA classification
Class II
Brand / firm
Fresenius Medical Care Holdings, Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

Expansion of recall to lots manufactured in 2015 due to the potential for 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 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

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