ICU Medical Inc: Medical Device Recall in 2023 - (Recall #: Z-2430-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 300103414, 300104213, 300105413, 300105713, 300106313, 300106513, 300106581, 300107813, 300107814, 300108513, 300108813, 300108814, 300109913; infusion pump

Product Classification:

Class II

Date Initiated: July 13, 2023

Date Posted: August 30, 2023

Recall Number: Z-2430-2023

Event ID: 92630

Reason for Recall:

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.

Status: Ongoing

Product Quantity: 93135 devices

Code Information:

UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated