ICU Medical Inc Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Brand
ICU Medical Inc
Lot Codes / Batch Numbers
All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower
Products Sold
All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower
ICU Medical Inc is recalling Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 due to Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than ex. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
ICU medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 03/22/2023 to its direct and indirect consignees by mail. The notice explained the issue and the hazard and requested the following: Clinical Users: Whenever possible, keep the pump plugged into AC power. Before disconnecting the pump from AC power, please ensure that the battery is fully charged. Closely monitor the Battery Status Indicator while the pump is disconnected from AC power. Additionally, have a backup pump available when infusing critical medications. Biomedical Engineering: You may replace affected batteries with a new CSB battery until corrected batteries are available. Please do not use a replacement battery with corroded battery terminals. 1. Identify all affected batteries in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to icumedical5967@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical5967@sedgwick.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026