Device recall
Z-1676-2025: Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile…
FDA device recall · Class II · Belmont Instrument LLC
Key facts
| Recall number (Z-number) | Z-1676-2025 |
|---|---|
| Recall event | 96617 |
| Product | Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight… |
| Product code | LGZ |
| Recalling firm | Belmont Instrument LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152208 |
| FEI number | 1219702 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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