FDA recall Z-1360-2022

Isopure Corp · Class II · device

Product

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-04-28
Report date
2022-07-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1360-2022