Recall Z-2759-2026 ยท LGZ Warmer, Thermal, Infusion Fluid
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
| Date | Jul 17, 2026 (initiated Jun 24, 2026) |
| Status | Open, Classified |
| 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. Sha |
| Quantity | 39,750 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911383 | HOTLINE FLUID WARMER Level 1 Technologies, Inc., Oct 17, 1991 |