Device recall
Z-2465-2023: LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC…
FDA device recall · Class II · Cardiac Assist, Inc
Key facts
| Recall number (Z-number) | Z-2465-2023 |
|---|---|
| Recall event | 92748 |
| Product | LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17 |
| Product code | KFM |
| Recalling firm | Cardiac Assist, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 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