Medical device recalls Moderate risk

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.

Get recall alerts

Free email alert whenever Fresenius Medical Care Holdings, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Fresenius Medical Care Holdings, Inc.