FDA DeviceClass IINotable

FDA Recall: ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403;

Date: 2026-07-22
Brand: ICU Medical, Inc.
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

12525 units

Related Recalls