Class 1 Device Recall Plum A & Plum A3 Infusion Systems

• Date Initiated by Firm: May 07, 2024
• Date Posted: August 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2449-2024
• Recall Event ID: 94690
• 510(K)Number: K042081 K070398
• Product Classification: Pump, infusion - Product Code FRN
• Product: Plum 360/A+ spare batteries. Item Number: SUB0000864.
• Code Information: 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.
• Recalling Firm/ Manufacturer: ICU Medical Inc; 600 N Field Dr; Lake Forest IL 60045-4835
• Manufacturer 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.
• FDA Determined 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN