Device recall
Z-0001-2017: CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI…
FDA device recall · Class III · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-0001-2017 |
|---|---|
| Recall event | 75118 |
| Product | CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired. |
| Product code | DRY |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 26, 2016 |
| 510(k) numbers | K915265 |
| FEI number | 3000204839 |
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