Isopure Corp recalls Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with r…

Recall date

July 26, 2022

Source

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

Recall number

Z-1739-2022

FDA classification

Class II

Brand / firm

Isopure Corp

Sold / distributed

US Nationwide distribution.

Why it was recalled

Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

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

What was recalled

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262