Device recall
Z-1193-2023: MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device…
FDA device recall · Class II · Unetixs Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-1193-2023 |
|---|---|
| Recall event | 91564 |
| Product | MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01 |
| Product code | JAF |
| Recalling firm | Unetixs Vascular, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K904392 |
| FEI number | 1222117 |
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