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...
Recall Summary ICU Medical is recalling certain lots of its Hotline Fluid Warming Set, a single-use device that warms blood and IV fluids before delivering them to patients. The sets may leak due to a manufacturing defect where solvent was not applied adequately at the connection between the tubing and return connector. The recall affects products distributed nationwide across all U.S. states and territories.
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-24
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/d27f4bc0-b827-4bad-8bb3-01569fc760b6