Device recall
Z-0629-2018: Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product…
FDA device recall · Class II · Cincinnati Sub-Zero Products LLC
Key facts
| Recall number (Z-number) | Z-0629-2018 |
|---|---|
| Recall event | 78173 |
| Product | Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits… |
| Product code | DWC |
| Recalling firm | Cincinnati Sub-Zero Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2018 |
| 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