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Hotline Fluid Warming Set
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MEDICAL DEVICE RECALLMODERATE

Hotline Fluid Warming Set

ICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.

What to do

Immediately inspect inventory for the affected lots and discontinue use of any identified units. Contact ICU Medical customer service for return and replacement instructions.

Posted
Updated
Agency
Firm
ICU Medical Inc.
Recall ID
99289
Status
ONGOING

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?

This recall covers the product below. If you have it, yours is affected.

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

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Editorial summary by Recall Canary · last updated 2026-07-20 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification