Z-2430-2023Class II

Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418...

Name: Z-2430-2023 Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418...
Creator: ICU Medical Inc
Published: 2023-07-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-07-13 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical Inc began a recall of Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481... on 2023-07-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2430-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-13
Posted: 2023-08-18
Recalling firm: Abbott Medical
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
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 07/13/2023 via traceable mailing. The notice explained the issue, potential risk, and requested the following: Actions for Clinical Users: If your Plum 360 pump does not power on or indicates an Audio Alarm failure, please remove the pump from use and send the pump to Biomedical Engineering. Actions for Biomedical Engineering: If you have Plum 360 pumps with Audio Alarm failures, please contact ICU Medical. 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and required actions. 2. Complete and return the attached Response Form to [email protected] within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]. A similar notice was distributed specifically to consignees of instruments that were serviced which lists the specific serial numbers. The issue, potential risk, and actions are the same as the general notice.
Quantity in commerce: 93135 devices
Distribution: Worldwide
Product codes and lots: UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2430-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2430-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-18

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)