Device recall
Z-1106-2020: TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product…
FDA device recall · Class II · Cardiac Assist, Inc
Key facts
| Recall number (Z-number) | Z-1106-2020 |
|---|---|
| Recall event | 84611 |
| Product | TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to… |
| Product code | DWF |
| Recalling firm | Cardiac Assist, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2020 |
| 510(k) numbers | K162214 |
| FEI number | 3002228812 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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