BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-2449-2024 · Reported August 21, 2024

    Enforcement

    Recall Number
    Z-2449-2024
    Event ID
    94690
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2024
    Initiation Date
    May 7, 2024
    Classification Date
    August 9, 2024
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835, United States

    Description

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

    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.

    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.

    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.

    Quantity

    130,826 units