FDA-Device2022-07-20Class II
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Isopure Corp
Hazard
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.
Sold states
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.
Affected count
119
Manufactured in
11851 Plantside Dr, Louisville, KY, United States
Products
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1360-2022Don't want to check this manually?
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