Isopure Sodium Bicarbonate Mixing and Distribution System recalled over fire hazard

Recall date

April 28, 2022

Source

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

Official notice title

Isopure Corp recalls Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

Recall number

Z-1360-2022

FDA classification

Class II

Brand / firm

Isopure Corp

Sold / distributed

Domestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK PA TX UT VA WV No foreign distribution.

Why it was recalled

Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.

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)