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Pump, Infusion
FDA product code FRN · Class 2 · General Hospital
946
Registered devices
1,827,003
Adverse events
720
Recalls
849
510(k) clearances
Devices with this code
PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC.Z-800 — ZYNO MEDICAL LLCAlaris — CAREFUSION 303, INC.Refurbished BodyGuard® 575 Pump — CME AMERICA LLCRemunityPRO — United Therapeutics CorporationMEDFUSION — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.Dutch, Rapid Infuser RI-2, 230V, 750 ml/min — BELMONT INSTRUMENT CORPORATIONSPECTRUM WITH MDL — BAXTER INTERNATIONAL INC.PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC.Infusomat® — B. BRAUN MEDICAL INC.Curlin Administration Set — ZEVEX INTERNATIONAL, INC.Plum — ICU Medical, Inc.Ivenix, Inc. — Fresenius Kabi AGItalian, Rapid Infuser, 230 V, 1000ml/min — BELMONT INSTRUMENT CORPORATIONElution Test Vial — Bracco Diagnostics Inc.Iradimed — IRADIMED CORP.MEDFUSION — ICU MEDICAL, INC.Fluid Replacement Supply — BELMONT INSTRUMENT CORPORATIONUK, Rapid Infuser RI-2, 230V, 1000 ml/min — BELMONT INSTRUMENT CORPORATIONCADD — ICU MEDICAL, INC.Medfusion — ICU MEDICAL, INC.Volumat™ Line — Fresenius Kabi AGPORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC.
Recent 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 (VTB |
| 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 (VTB |
| 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 |
| 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 |
| 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 d |
| 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 no |
| 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 startin |
| 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 startin |
| 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 startin |
| 2026-02-11 | CareFusion 303, Inc. | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communicatio |
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