Device recall
Z-1491-06: Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product…
FDA device recall · Class II · Cobe Cardiovascular, Inc
Key facts
| Recall number (Z-number) | Z-1491-06 |
|---|---|
| Recall event | 36168 |
| Product | Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc. |
| Product code | CAC |
| Recalling firm | Cobe Cardiovascular, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2011 |
| 510(k) numbers | K020647 |
| FEI number | 1718850 |
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