Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

FDA Recall Z-1360-2022 · Posted None

Recalling FirmIsopure Corp
Recall StatusOpen, Classified
Product CodeFIN
Date Initiated2022-04-28
Product Quantity119

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112427BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp. · 2012-01-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑