FDAFDA · Food and drugs·Recall number Z-2759-2026
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
Published July 29, 2026 · Recall initiated: June 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical Inc.
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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