BEUDAMED
    FDA Enforcement Class I Ongoing

    ASM Replacement Battery, Component Number SUB0000594

    Recall: Z-1568-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1568-2023
    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

    ASM Replacement Battery, Component Number SUB0000594

    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

    Lot Numbers: 5660479

    Distribution

    worldwide

    Quantity

    344 units