Device recall
Z-1486-2021: Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous…
FDA device recall · Class II · Cardiac Assist, Inc
Key facts
| Recall number (Z-number) | Z-1486-2021 |
|---|---|
| Recall event | 87632 |
| Product | Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr) |
| Product code | DRE |
| Recalling firm | Cardiac Assist, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 22, 2021 |
| 510(k) numbers | K162181 |
| FEI number | 3002228812 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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