BEUDAMED
    FDA Enforcement Class I Ongoing

    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973

    Recall: Z-1566-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1566-2023
    Event ID
    91874
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2023
    Initiation Date
    March 22, 2023
    Classification Date
    May 16, 2023
    Address
    600 N Field Dr, N/A, Lake Forest, IL, 60045-4835, United States

    Description

    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973

    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

    All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower

    Distribution

    worldwide

    Quantity

    23815 units