FDA Medical Device Recalls (openFDA)
ICU Medical Inc: Plum 360/A+ spare batteries. Item Number: SUB0000864.
- Recall number
- Z-2449-2024
- Recalling firm
- ICU Medical Inc
- Product
- Plum 360/A+ spare batteries. Item Number: SUB0000864.
- Status
- Open, Classified
- Initiated
- 2024-05-07
- Posted
- 2024-08-09
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- Consignees were notified on about 05/07/2024 via traceable mail with an "UPDATED URGENT MEDICAL DEVICE CORRECTION" letter to the original recall was expanding. Consignees were instructed to replace batteries the first time the pump issues a replace battery alarm. Continued use of pumps on battery after the first instance of the replace battery alarm will reduce the time from a low battery alarm to a depleted battery/infusion stopping. Additionally, pumps should be kept plugged into AC power, closely monitor if using battery power, have a backup pump available, and do not use a replacement battery with corroded battery terminals. Customers were also requested to ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations, and to complete and return the provided Response Form. For distributors, if the affected products have been potentially distributed, to immediately forward the notification to customers. For further inquiries, please contact ICU Medical using the following information: Global Complaint Management, 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or ProductComplaintsPP@icumed.com to report adverse events or product complaints; Technical Support 1-800-241-4002 (M-F, 8:00 am 6:00 pm CT) -additional information for technical assistance; or Field Corrections https://icumed.custhelp.com/app/market-action for Questions about this Field Correction Notice.
- Quantity
- 130,826 units
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
- Lot, serial or model codes
- Item Number: SUB0000864; Lot Numbers: 13620902, 13588166, 13651642, 13651688, 13651686, 13651685, 13492940, 13498252, 13498259, 13716418, 13716411, 13651680, 13620909, 13716514, 13588168, 13594285, 13620897, 13638726, 13620893, 13594289, 13638724, 13651671, 13594281, 13620898, 13659496, 13638723, 13594280, 13638728, 13588163, 13588169, 13588170, 13651640, 13638727, 13618384, 13769263, 13588165, 13588161, 13716427, 13570187, 13765276, 13651678, 13746712, 13749803, 13771023, 13771500, 13716336, 13588159, 13716329, 13594286, 13594287, 13620905, 13651677, 13594282.
- 510(k) numbers
- ["K042081","K070398"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28