Device recall
Z-0063-2019: Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir…
FDA device recall · Class II · Cincinnati Sub-Zero Products LLC, a Gentherm Company
Key facts
| Recall number (Z-number) | Z-0063-2019 |
|---|---|
| Recall event | 80941 |
| Product | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm 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 cardiopulmonary bypass procedures lasting six hours… |
| Product code | DWC |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2019 |
| 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