Device recall
Z-2759-2026: Hotline Fluid Warming Set, single use device, is designed to warm blood and…
FDA device recall · Class II · ICU Medical Inc.
Key facts
| Recall number (Z-number) | Z-2759-2026 |
|---|---|
| Recall event | 99289 |
| Product | Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70 |
| Product code | LGZ |
| Recalling firm | ICU Medical Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K911383 |
| FEI number | 3012307300 |
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