Reported Jul 29, 2026 · Ongoing
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the…
ICU Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI30695085407007
- Lot Numbers
42935684293569429751042975094326087433772443377254346349
- Amount recalled
- 39,750 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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