Device recall
Z-1248-06: Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation…
FDA device recall · Class II · Celsion Corporation
Key facts
| Recall number (Z-number) | Z-1248-06 |
|---|---|
| Recall event | 35573 |
| Product | Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, labeled in part ***… |
| Product code | MEQ |
| Recalling firm | Celsion Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2011 |
| 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