Device recall
Z-1678-2025: 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N…
FDA device recall · Class II · Belmont Instrument LLC
Key facts
| Recall number (Z-number) | Z-1678-2025 |
|---|---|
| Recall event | 96625 |
| Product | 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment… |
| Product code | LGZ |
| Recalling firm | Belmont Instrument LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K242735 |
| 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