Device recall
Z-0044-2022: ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange…
FDA device recall · Class II · ZOLL Circulation, Inc.
Key facts
| Recall number (Z-number) | Z-0044-2022 |
|---|---|
| Recall event | 88671 |
| Product | ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510 |
| 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