Device recall
Z-2554-2011: 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary…
FDA device recall · Class I · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-2554-2011 |
|---|---|
| Recall event | 58762 |
| Product | 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The… |
| Product code | DWF |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 21, 2012 |
| 510(k) numbers | K822210 |
| FEI number | 1828100 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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