FDA-Device2026-07-29Class IIPROCESSING DEFECT
ICU Medical Hotline Fluid Warming Set recalled for leakage risk due to connector bond defect
OTHERNationwide distribution
ICU Medical Hotline Fluid Warming Set recalled for leakage risk
ICU Medical's Hotline Fluid Warming Set (model L-70), a single-use device used to warm blood and IV fluids before delivery to patients, may leak due to inadequate solvent application at the tubing-to-connector bond in certain production lots. This defect could affect proper fluid delivery during patient care.
- Check your facility's inventory for affected lot numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349.
- If you have affected units, contact your ICU Medical representative or hospital supply chain for instructions.
- Do not use affected lots for patient care.
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
39,750 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2759-2026Don't want to check this manually?
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