Drug recall
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA recall event 90389 · Class II · Isopure Corp
Key facts
| Event ID | 90389 |
|---|---|
| Recall numbers | Z-1360-2022 |
| Recalling firm | Isopure Corp |
| Product type | Devices |
| Products | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 28, 2022 |
| Report date | Jul 20, 2022 |
| City | Louisville |
| State | KY |
| Country | United States |
| FEI number | 3013942511 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: