ICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
ICU Medical is recalling specific lots of Hotline Fluid Warming Sets due to an increased likelihood of leakage from inadequate solvent application at the tubing to return connector bond.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with risk-of-harm potential where injury has not yet been reported. The leakage issue in a fluid warming device used for patient care presents a potential patient safety risk, warranting High severity despite no reported injuries.
Plain-English summary
ICU Medical Inc. is recalling approximately 39,750 Hotline Fluid Warming Sets, single use devices designed to warm blood and intravenous fluids for patient administration. The recall affects specific lots identified by UDI-DI 30695085407007 and eight lot numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, and 4346349.
The company identified an increased likelihood of leakage in these specific lots due to potentially inadequate solvent application at the tubing to return connector bond. This manufacturing issue could compromise the device's ability to safely deliver warmed fluids to patients.
The affected devices were distributed worldwide, including throughout the United States. No injuries, illnesses, or deaths have been reported in connection with this issue.
Healthcare facilities and patients using these devices should immediately stop use and contact ICU Medical Inc. for replacement devices. Users should inspect their inventory for the affected lot numbers and UDI-DI. Any affected devices in use should be removed from service and disposed of according to medical waste protocols.
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
- Manufacturer
- ICU Medical Inc.
- Affected units
- 39,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI-DI: 30695085407007
- Lot Numbers: 4293568
- 4293569
- 4297510
- 4297509
- 4326087
- 4337724
- 4337725
- 4346349
Distribution
Distributed nationwide across the United States.
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