Device recall
Z-0926-2023: SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT…
FDA device recall · Class I · Cardiac Assist, Inc
Key facts
| Recall number (Z-number) | Z-0926-2023 |
|---|---|
| Recall event | 91362 |
| Product | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit. |
| Product code | DWA |
| Recalling firm | Cardiac Assist, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 8, 2023 |
| 510(k) numbers | K183623 |
| 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