BEUDAMED
    FDA Enforcement Class I Ongoing

    Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

    Recall: Z-1080-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1080-2024
    Event ID
    93807
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 28, 2024
    Initiation Date
    December 22, 2023
    Classification Date
    February 16, 2024
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

    Reason

    Sterility assurance for saline included in surgical kits cannot be guaranteed.

    Code Info

    UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582

    Distribution

    US: FL, IL, CA OUS: None

    Quantity

    128 kits