—#209046

Product

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042081, K070398
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: ICU Medical Inc
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-05-07
Posted by FDA: 2024-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209046. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.