Device recall
Z-0182-2014: Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene…
FDA device recall · Class II · Urologix, Inc.
Key facts
| Recall number (Z-number) | Z-0182-2014 |
|---|---|
| Recall event | 66598 |
| Product | Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic… |
| Product code | GEI |
| Recalling firm | Urologix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2014 |
| 510(k) numbers | K113380 |
| FEI number | 3000718675 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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