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Level 1

ICU MEDICAL, INC. · Model HL-390-38 · UDI-DI 10695085002826

LGZ Prescription

510(k) clearances

6,999

Adverse events (48 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2026-06-24	ICU Medical Inc.	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 t
2025-04-22	3M Company	Notice was issued to clarify flow rates related to the inlet fluid temperature.
2025-03-31	Belmont Instrument LLC	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
2025-03-31	Belmont Instrument LLC	Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
2025-03-31	Belmont Instrument LLC	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
2025-03-31	Belmont Instrument LLC	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
2021-08-06	Smiths Medical ASD Inc.	There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
2021-08-06	Smiths Medical ASD Inc.	There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
2021-06-04	Eight Medical International BV	The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
2021-04-30	RanD S.r.l.	The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.