Device recall
Z-0832-2011: Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is…
FDA device recall · Class II · Galil Medical
Key facts
| Recall number (Z-number) | Z-0832-2011 |
|---|---|
| Recall event | 57254 |
| Product | Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when… |
| Product code | GEH |
| Recalling firm | Galil Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| 510(k) numbers | K010991 |
| FEI number | 3004462490 |
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