FDAClass IIAugust 30, 2023

Plum 360 Infusion System recall

Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481…

Why was Plum 360 Infusion System recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481…
Recalling firm
ICU Medical Inc
Quantity
93135 devices
Distribution
Worldwide
Recall date
August 30, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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