Device recall
Z-2092-2021: Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no…
FDA device recall · Class II · Gentherm Medical, LLC
Key facts
| Recall number (Z-number) | Z-2092-2021 |
|---|---|
| Recall event | 88187 |
| Product | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures |
| Product code | DWC |
| Recalling firm | Gentherm Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2023 |
| 510(k) numbers | K122813 |
| FEI number | 1516825 |
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