FDA Device recall Z-1360-2022
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) by Isopure, citing 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 compon….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1360-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-28 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Isopure |
| Distribution | AL, AZ, CO, DE, FL, GA, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, NY, OK, PA, TX, UT, VA, WV |
Product
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
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.
Identifiers
| code_info | UDI-DI: 00852456007085 Serial numbers: SERIAL # IMP-113766 5202061411P 5201081501 IMP-112232 IMP-120373 IMP-112737 IMP…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 IM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1360-2022%22
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