Hotline Fluid Warming Set
ICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
Immediately inspect inventory for the affected lots and discontinue use of any identified units. Contact ICU Medical customer service for return and replacement instructions.
Recall at a glance
- Quantity recalled
- 39,750 units
Why it was recalled
ICU Medical is recalling specific lots of the Hotline Fluid Warming Set due to a risk of leakage at the tubing-to-connector bond caused by inadequate solvent application. This defect may compromise the delivery of warmed blood and intravenous fluids to patients.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Hotline Fluid Warming Set, single use device
- Lot code
- 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
- UDI-DI
- 30695085407007
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-07-20 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification