Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is

FDA device recall Z-2447-2024 · posted 2024-08-09 · Open, Classified

Recall details

Recalling firm

ICU Medical Inc

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

FRN

Quantity affected

11,961 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, Taiw

Date initiated

2024-05-07

Date posted

2024-08-09

Location

Lake Forest, IL

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