BEUDAMED
    FDA Enforcement Class II Ongoing

    Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

    Recall: Z-1621-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1621-2023
    Event ID
    92288
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    May 31, 2023
    Initiation Date
    April 24, 2023
    Classification Date
    May 23, 2023
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

    Reason

    Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

    Code Info

    Lot 188843; UDI: B098AMS4601E0

    Distribution

    US: MA OUS: None

    Quantity

    60 kits