Sodium Bicarbonate System (Isopure) – electrical short risk (2022)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Firm began to call customers on April 28, 2022, to determine if the IsoMix Pro is still in use at each location. The firm will also be sending an email out to all clinics along with an updated Safety Notice. Once information is gathered, service technicians will visit each clinic to assess the devices. Customers will be provided with a video link as part of an inspection packet on proper use of a torque screwdriver. Customers should follow the provided guidance documents. Customers should always replace any depleted or blown fuses with the correct size. Customers are also instructed to follow the recommended preventive maintennace schedule for the device.

Distribution

As reported by FDA

AL, AZ, CO, DE, FL, GA, IN, KS, KY, LA, ME, MD, MA, MN, MO, NY, NC, OK, PA, TX, UT, VA, WV