Device recall
Z-0825-2019: Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The…
FDA device recall · Class II · Cincinnati Sub-Zero Products LLC, a Gentherm Company
Key facts
| Recall number (Z-number) | Z-0825-2019 |
|---|---|
| Recall event | 81961 |
| Product | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during… |
| Product code | DWC |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2020 |
| 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