ICU Medical Hotline Fluid Warming Set recalled for leakage risk due to connector bond defect
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.
From the FDA notice · Read the official notice ↗ · All ICU Medical recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 39,750 units
- Illnesses reported
- None reported
- Manufactured in
- 6000 Nathan Ln N, N/A, Minneapolis, MN, United States
- Classification
- Class II
- Recall number
- Z-2759-2026
In the FDA's words
- Description
- 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 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. UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349 Distribution: Worldwide - US Nationwide distribution. Affected quantity: 39,750 units
- 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.