Class I recallOngoing

ICU Medical Plum 360 Infusion System recall — FDA event 95586

FDA · FDA event 95586 · Posted Nov 21, 2024

Published Nov 21, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

ICU Medical issued an "URGENT MEDICAL DEVICE SAFETY ALERT" on 10/22/2024 via letter. The notice explained the issue, potential risk of use, and requested that all affected products be removed from use and destroyed. Distributors were directed to forward the notice to their customers.
For further inquiries: Additional information or technical assistance: Technical Support, 1-800-241-4002 (M-F, 8:00 am 6:00 pm CT);
To report adverse events or product complaints: Global Complaint Management, 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or ProductComplaintsPP@icumed.com.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references ICU Medical Plum 360 Infusion System by ICU Medical, Inc..

Products affected by FDA event 95586
Model	Description	Lot / serial range	Manufactured	Status
Z-0482-2025	Z-0482-2025	All batteries WITHOUT the following information on the label: 1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery): W2401xxxx - W2406xxx	Not provided in the normalized record	Ongoing

Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Oct 22, 2024
Recall initiated
Date recorded by the FDA.
Nov 21, 2024
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 95586
Published: Nov 21, 2024
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

Class I recallOngoing

ICU Medical Plum 360 Infusion System recall — FDA event 94690

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

FDA · FDA event 94690Posted Aug 9, 2024ICU Medical Plum 360 Infusion System

Class II recallOngoing

ICU Medical Plum 360 Infusion System recall — FDA event 92630

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.

FDA · FDA event 92630Posted Aug 18, 2023ICU Medical Plum 360 Infusion System

Loading MedWatcher information…

ICU Medical Plum 360 Infusion System recall — FDA event 95586

FDA · FDA event 95586 · Posted Nov 21, 2024

Published Nov 21, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 95586
Model	Description	Lot / serial range	Manufactured	Status
Z-0482-2025	Z-0482-2025	All batteries WITHOUT the following information on the label: 1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery): W2401xxxx - W2406xxx	Not provided in the normalized record	Ongoing

Distribution

Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay.

Units affected

See official FDA record

ICU Medical Plum 360 Infusion System recall — FDA event 94690

FDA · FDA event 94690Posted Aug 9, 2024ICU Medical Plum 360 Infusion System

Class II recallOngoing

ICU Medical Plum 360 Infusion System recall — FDA event 92630

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.

FDA · FDA event 92630Posted Aug 18, 2023ICU Medical Plum 360 Infusion System

ICU Medical Plum 360 Infusion System recall — FDA event 95586

Follow ICU Medical Plum 360 Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

ICU Medical Plum 360 Infusion System recall — FDA event 95586

Follow ICU Medical Plum 360 Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline