Device recall
Z-1502-2022: UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
FDA device recall · Class II · Neotract Inc
Key facts
| Recall number (Z-number) | Z-1502-2022 |
|---|---|
| Recall event | 90548 |
| Product | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool |
| Product code | PEW |
| Recalling firm | Neotract Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193269 |
| FEI number | 3005791775 |
At a glance
- 1–9 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