BEUDAMED
    FDA Enforcement Class III Ongoing

    Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

    Recall: Z-1817-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1817-2022
    Event ID
    90809
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    September 2, 2022
    Classification Date
    September 26, 2022
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

    Reason

    Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

    Code Info

    All serial numbers after 6/2016. Product code CMMST5 - Incorrect UDI-DI: 7290013030269; correct UDI-DI: 07290013030269. Product code CMM-ST5 - Incorrect UDI-DI: 7290013030030; correct UDI-DI: 07290013030030. Product code CMABATT - Incorrect UDI-DI: 7290013030160; correct UDI-DI: 07290013030160. Product code CMASC10 - Incorrect UDI-DI: 7290013030054; correct UDI-DI: 07290013030054.

    Distribution

    US Nationwide Distribution and government/military distribution.

    Quantity

    9,671 units