Device recall
Z-0417-2020: Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature…
FDA device recall · Class II · Cincinnati Sub-Zero Products LLC, a Gentherm Company
Key facts
| Recall number (Z-number) | Z-0417-2020 |
|---|---|
| Recall event | 83464 |
| Product | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. |
| Product code | DWJ |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2020 |
| 510(k) numbers | K101589 |
| 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