Device recall
Z-0843-06: Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation…
FDA device recall · Class III · Celsion Corporation, Inc.
Key facts
| Recall number (Z-number) | Z-0843-06 |
|---|---|
| Recall event | 34988 |
| Product | Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion… |
| Product code | MEQ |
| Recalling firm | Celsion Corporation, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 7, 2007 |
| 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