Z-0482-2025Class I

Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum...

Name: Z-0482-2025 Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum...
Creator: ICU Medical, Inc.
Published: 2024-10-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-10-22 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+... on 2024-10-22. FDA classified it as Class I and gives the reason as "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...". 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-0482-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-22
Posted: 2024-11-21
Recalling firm: Abbott Medical
Product: Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected].
Quantity in commerce: 3840
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0482-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-21

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)