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 temperature
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
- Agency
- FDA Device
- Recall date
- Jun 24, 2026
- Status
- Ongoing
- Company
- ICU Medical Inc.
1. What product was recalled?
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 temperature
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
Quantity: 39,750 units
Code or lot text: UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
- LOT
- 4293569
- LOT
- 4297509
- LOT
- 4297510
- LOT
- 4326087
- LOT
- 4337724
- LOT
- 4337725
- LOT
- 4346349
- LOT
- Lot Numbers: 4293568
- LOT
- UDI-DI: 30695085407007
- RECALL-NUMBER
- Z-2759-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.