Device recall
Z-2721-2011: ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This…
FDA device recall · Class II · Cincinnati Sub-Zero Products Inc
Key facts
| Recall number (Z-number) | Z-2721-2011 |
|---|---|
| Recall event | 58971 |
| Product | ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended… |
| Product code | DWJ |
| Recalling firm | Cincinnati Sub-Zero Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2013 |
| 510(k) numbers | K811742 |
| 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