Device recall
Z-2735-2011: System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann…
FDA device recall · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-2735-2011 |
|---|---|
| Recall event | 58547 |
| Product | System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional |
| Product code | DTQ |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2013 |
| 510(k) numbers | K022947 |
| 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