BEUDAMED
    FDA Enforcement Class I Ongoing

    Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

    Recall: Z-1079-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1079-2024
    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, Local Lower Extremity Pack I, AMS10833, STERILEEO

    Reason

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

    Code Info

    DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297

    Distribution

    US: FL, IL, CA OUS: None

    Quantity

    1,528 units