Device recall
Z-1944-2011: Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen…
FDA device recall · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-1944-2011 |
|---|---|
| Recall event | 57189 |
| Product | Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. |
| Product code | DTY |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K902654 |
| FEI number | 1828100 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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