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Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

FDA Device Recall #Z-1360-2022 — Class II — April 28, 2022

Recall Summary

Recall Number Z-1360-2022
Classification Class II — Moderate risk
Date Initiated April 28, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Isopure Corp
Location Louisville, KY
Product Type Devices
Quantity 119

Product Description

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 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.

Lot / Code Information

UDI-DI: 00852456007085 Serial numbers: SERIAL # IMP-113766 5202061411P 5201081501 IMP-112232 IMP-120373 IMP-112737 IMP-112606 IMP-113620 IMP-113580 IMP-113085 IMP-112842 IMP-113812 IMP-119050 IMP-113811 IMP-114975 IMP-113810 IMP-115147 IMP-115148 IMP-116155 IMP-116060 IMP-117241 IMP-115146 IMP-115145 IMP-116662 IMP-116996 IMP-117110 IMP-117278 IMP-117739 IMP-117979 IMP-118086 IMP-118103 IMP-118376 IMP-118568 IMP-118704 IMP-118765 IMP-119049 IMP-119343 IMP-118802 IMP-119503 IMP-119757 IMP-119788 IMP-120188 IMP-120172 IMP-120238 IMP-120699 IMP-120187 IMP-114976 IMP-119872 IMP-120959 IMP-120890 IMP-121099 IMP-121101 IMP-121883 IMP-117219 IMP-121980 IMP-122289 IMP-122582 IMP-122943 IMP-115144 IMP-123041 IMP-124680 IMP-825374 IMP-124893 IMP-825418 IMP-124862 IMP-124679 IMP-825865 IMP-826655 IMP-826884 IMP-826438 IMP-826928 IMP-826544 IMP-827363 IMP-827511 IMP-827244 IMP-830445 IMP-826812 IMP-827461 IMP-119513 IMP-827602 IMP-828401 IMP-119388 IMP-121100 IMP-829313 IMP-830965 IMP-831004 IMP-122583 IMP-830617 IMP-831413 IMP-831594 IMP-831197 IMP-831894 IMP-831929 IMP-832283 IMP-832381 IMP-832706 IMP-113809 IMP-832925 IMP-833088 IMP-833120 IMP-833428 IMP-833769 IMP-833916 IMP-833942 IMP-830374 IMP-120755 IMP-834278 IMP-833473 IMP-834575 IMP-834798 IMP-123026 IMP-835190 IMP-835138 IMP-835454 IMP-835973 IMP-838703 IMP-839160 IMP-840230 IMP-840914 IMP-831334 IMP-120670

Other Recalls from Isopure Corp

Recall # Classification Product Date
Z-1739-2022 Class II Acidified Concentrate Distribution and Storage-... Jul 26, 2022
Z-0821-2020 Class II Acidified Concentrate Distribution and Storage ... Apr 19, 2019
Z-0822-2020 Class II Isopure Sodium Bicarbonate Mixing and Distribut... Apr 19, 2019
Z-0823-2020 Class II Finish Thompson Centrifugal Pump Model #110192-... Apr 19, 2019

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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