Medivators, Inc. recalls Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatibl…

Recall date

April 20, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1859-2021

FDA classification

Class II

Brand / firm

Medivators, Inc.

Sold / distributed

US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.

Why it was recalled

The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.