ICU Medical Inc. recalls Hotline Fluid Warming Set

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.

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

An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 6/24/26 was sent to customers. Actions for Users: When using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below. 1. Locate potentially affected devices from the Lots listed in Table 1 above. 2. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 3. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure that this communication is delivered there. 4. Complete and return the attached Customer Response Form to MarketAction@mailac.custhelp.com within 10 days of receipt to acknowledge your understanding of this notification. Required Actions for Distributors: When using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below. 1. Locate potentially affected devices from the Lots listed in Table 1 above. 2. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 3. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure that this communication is delivered there. 4. Complete and return the attached Customer Response Form to MarketAction@mailac.custhelp.com within 10 days of receipt to acknowledge your understanding of this notification. 5. DISTRIBUTORS: Immediately forward this notice to all users to whom you distributed these products. IC

• FDA enforcement recordOfficial FDA database entry for Z-2759-2026
• FDA 510(k) clearance · K911383The device's official FDA premarket clearance record
• FDA device classification · LGZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ICU Medical Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.