Device recall
Z-0127-06: AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation, 682…
FDA device recall · Class III · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-0127-06 |
|---|---|
| Recall event | 33323 |
| Product | AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made… |
| Product code | KRD |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 13, 2006 |
| 510(k) numbers | K031810 |
| FEI number | 3005334138 |
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