Device recall
Z-1339-04: Prolieve Thermodilatation System, model number M0068808000, labeled in…
FDA device recall · Class II · Celsion Corporation
Key facts
| Recall number (Z-number) | Z-1339-04 |
|---|---|
| Recall event | 29633 |
| Product | Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046*** |
| Product code | MEQ |
| Recalling firm | Celsion Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2005 |
| PMA numbers | P030006 |
| FEI number | 1122126 |
At a glance
- None Linked 510(k)s
- 1–9 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