Isopure product recalled over mold contamination

Recall date

April 19, 2019

Source

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

Official notice title

Isopure Corp recalls Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #1…

Recall number

Z-0822-2020

FDA classification

Class II

Brand / firm

Isopure Corp

Sold / distributed

The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.

Why it was recalled

There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.

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

What was recalled

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3