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Pump, Infusion
FDA product code FRN · Class 2 · General Hospital
950
Registered devices
1,835,899
Adverse events
721
Recalls
849
510(k) clearances
Devices with this code
B.BRAUN — B. BRAUN MEDICAL INC.PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC.Graseby — ICU MEDICAL, INC.Rapid Infuser Accessory Kit — BELMONT INSTRUMENT CORPORATIONVigilant Drug'Lib AGILIA US — Fresenius Kabi AG3-Spike Disposable Set (1 Piece) — BELMONT INSTRUMENT CORPORATIONCurlin — ZEVEX INTERNATIONAL, INC.Iradimed — IRADIMED CORP.ambIT — SUMMIT MEDICAL PRODUCTS, INC.Medfusion — ICU MEDICAL, INC.PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC.Refurbished BodyGuard® 575 ColorVision® Pump System — CME AMERICA LLCCADD — ICU MEDICAL, INC.PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC.Curlin — ZEVEX INTERNATIONAL, INC.T-34L Purple NeoFeed Enteral Pump — CME AMERICA LLCSwedish, Rapid Infuser RI-2, 230V, 1000 ml/min — BELMONT INSTRUMENT CORPORATIONCADD — ICU MEDICAL, INC.MEDRAD® Intego Patient Administration Set — BAYER MEDICAL CARE INC.Beeline motIV — Rex Pj Tech LLCMiniMed Reservoir — MEDTRONIC MINIMED, INC.ReShape Infiltration Pump — HK SURGICAL INC.NA — B. BRAUN MEDICAL INC.Outlook® — B. BRAUN MEDICAL 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 |
| 2026-05-12 | ICU Medical, Inc. | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride |
| 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 |
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