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Spanish, Rapid Infuser RI-2, 230V, 750 ml/min

BELMONT INSTRUMENT CORPORATION · Model 903-00039A-S · UDI-DI 60896128002772

FRN LGZ Prescription

510(k) clearances

Adverse events

721

Recalls

147

Facilities

Recalls

Date	Firm	Reason
2026-08-11	Baxter Healthcare Corporation	A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
2026-08-11	Baxter Healthcare Corporation	A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
2026-06-10	ICU Medical, Inc.	In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
2026-06-10	ICU Medical, Inc.	In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-05-06	Fresenius Kabi USA, LLC	Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless
2026-05-06	Fresenius Kabi USA, LLC	Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or rea
2026-04-29	ICU Medical, Inc.	Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may
2026-04-29	ICU Medical, Inc.	Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may
2026-04-29	ICU Medical, Inc.	Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may

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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.