FDA Medical Device Recalls (openFDA)
ICU Medical Inc.: 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
- Recall number
- Z-2759-2026
- Recalling firm
- ICU Medical Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2026-06-24
- Posted
- 2026-07-17
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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
- Quantity
- 39,750 units
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
- 510(k) numbers
- ["K911383"]
- PMA numbers
- not on file
- Product code
- LGZ
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28