Device recall
Z-0969-2012: Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number…
FDA device recall · Class II · Cincinnati Sub-Zero Products Inc
Key facts
| Recall number (Z-number) | Z-0969-2012 |
|---|---|
| Recall event | 60721 |
| Product | Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat… |
| Product code | DWJ |
| Recalling firm | Cincinnati Sub-Zero Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2013 |
| FEI number | 1516825 |
At a glance
- None 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