FDA Device recall Z-2430-2023

Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453,…

FDA Device
Class II
ongoing
Published 2023-08-30

On 2023-08-30 the FDA classified a Class II recall of Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453,… by Icu Medical, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2430-2023
Classification	Class II
Status	ongoing
Initiated	2023-07-13
Published	2023-08-30
Last updated	2026-09-13 11:56 UTC
Company	Icu Medical
Distribution	n/a

Product

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

Reason

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2430-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.