Z-2759-2026Class II

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

Name: Z-2759-2026 Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver...
Creator: ICU Medical Inc.
Published: 2026-06-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2026-06-24 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical Inc. began a recall of 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... on 2026-06-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2759-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-24
Posted: 2026-07-17
Recalling firm: Abbott Medical
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
Product code: LGZ Warmer, Thermal, Infusion Fluid
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected] 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 in commerce: 39,750 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2759-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2759-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17

Product code LGZ

K911383Class IIHotline Fluid WarmerLevel 1 Technologies, Inc. / cleared 1991-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)