Device recall
Z-0551-2009: Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for…
FDA device recall · Class II · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0551-2009 |
|---|---|
| Recall event | 49510 |
| Product | Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. |
| Product code | NLI |
| Recalling firm | Sterilmed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| 510(k) numbers | K043453 |
| FEI number | 3001237663 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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