Device recall
Z-0040-2022: Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular…
FDA device recall · Class II · ZOLL Circulation, Inc.
Key facts
| Recall number (Z-number) | Z-0040-2022 |
|---|---|
| Recall event | 88671 |
| Product | Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3 |
| Product code | NCX |
| Recalling firm | ZOLL Circulation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2024 |
| 510(k) numbers | K150046 |
| FEI number | 3003793491 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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