Recall Z-1360-2022 ยท FIN Tank, Holding, Dialysis
Isopure Corp
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
| Date | Apr 28, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| 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 |
| Quantity | 119 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM Isopure, Corp., Jan 26, 2012 |