Device recall
Z-0363-05: AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is…
FDA device recall · Class II · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-0363-05 |
|---|---|
| Recall event | 30481 |
| Product | AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin… |
| Product code | GBK |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 26, 2006 |
| FEI number | 3005334138 |
At a glance
- None Linked 510(k)s
- 10–99 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