Device recall
Z-1656-2012: ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136…
FDA device recall · Class II · Cincinnati Sub-Zero Products Inc
Key facts
| Recall number (Z-number) | Z-1656-2012 |
|---|---|
| Recall event | 61754 |
| Product | ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the fluid temperature. The device is composed of a heater, a circulating pump, fan, safety high limit… |
| 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