Z-2449-2024Class I

Plum 360/A+ spare batteries. Item Number: SUB0000864

Name: Z-2449-2024 Plum 360/A+ spare batteries. Item Number: SUB0000864
Creator: ICU Medical Inc
Published: 2024-05-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-05-07 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical Inc began a recall of Plum 360/A+ spare batteries. Item Number: SUB0000864 on 2024-05-07. FDA classified it as Class I and gives the reason as "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...". 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-2449-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-05-07
Posted: 2024-08-09
Recalling firm: Abbott Medical
Product: Plum 360/A+ spare batteries. Item Number: SUB0000864.
Product code: FRN Pump, Infusion
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2449-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2447-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-09
Z-2448-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-09
Z-2449-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-09

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)