Device recall
Z-1360-2022: Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA device recall · Class II · Isopure Corp
Key facts
| Recall number (Z-number) | Z-1360-2022 |
|---|---|
| Recall event | 90389 |
| Product | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) |
| Product code | FIN |
| Recalling firm | Isopure Corp |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K112427 |
| FEI number | 3013942511 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database