Device recall
Z-2166-2026: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-2166-2026 |
|---|---|
| Recall event | 98696 |
| Product | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit… |
| Product code | HIG |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172048 |
| FEI number | 2936485 |
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