Device recall
Z-1353-04: Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, steerable…
FDA device recall · Class II · Terumo Cardiovascular Systems Corp
Key facts
| Recall number (Z-number) | Z-1353-04 |
|---|---|
| Recall event | 29475 |
| Product | Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, steerable stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5585. |
| Product code | DWF |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2004 |
| 510(k) numbers | K922471 |
| FEI number | 1828100 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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