Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p

FDA device recall Z-2759-2026 · posted 2026-07-17 · Open, Classified

Recall details

Recalling firm

ICU Medical Inc.

Reason for recall

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.

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

LGZ

Quantity affected

39,750 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2026-06-24

Date posted

2026-07-17

Location

Minneapolis, MN

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