FDAHealthJune 24, 2026
ICU Medical Inc. — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 24, 2026
Worldwide - US Nationwide distribution.
What's affected?
- 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
- Brand
- ICU Medical Inc.
- Lot code
- 4293568
Additional details
UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 39,750 units.
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